Date of Define-XML document generation: 2016-07-08T05:48:25-04:00
Define-XML version: 2.0.0
Stylesheet version: 2016-07-05
- Standard
- SDTM-IG 3.1.2
- Study Name
- CDISC01
- Study Description
- CDISC Test Study
- Protocol Name
- CDISC01
- Metadata Name
- Data Definitions for CDISC01, SDTM-IG 3.1.2
- Metadata Description
- Data Definitions for CDISC01, SDTM-IG 3.1.2
Tabulation Datasets for Study CDISC01 (SDTM-IG 3.1.2)
Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
---|---|---|---|---|---|---|---|
TA | Trial Arms | TRIAL DESIGN | One record per planned Element per Arm | Tabulation | STUDYID, ARMCD, TAETORD | ta.xpt | |
TE | Trial Elements | TRIAL DESIGN | One record per planned Element | Tabulation | STUDYID, ETCD | te.xpt | |
TI | Trial Inclusion/Exclusion Criteria | TRIAL DESIGN | One record per I/E criterion | Tabulation | STUDYID, IETESTCD | ti.xpt | |
TS | Trial Summary | TRIAL DESIGN | One record per trial summary parameter value | Tabulation | STUDYID, TSPARMCD, TSSEQ | ts.xpt | |
TV | Trial Visits | TRIAL DESIGN | One record per planned Visit per Arm | Tabulation | STUDYID, VISITNUM, ARMCD | tv.xpt | |
DM | Demographics | SPECIAL PURPOSE | One record per subject | Tabulation | STUDYID, USUBJID | dm.xpt | See Reviewer's Guide, Section 2.1 Demographics |
SE | Subject Elements | SPECIAL PURPOSE | One record per actual Element per subject | Tabulation | STUDYID, USUBJID, SESTDTC, SEENDTC, TAETORD, ETCD | se.xpt | |
SV | Subject Visits | SPECIAL PURPOSE | One record per actual visit per subject | Tabulation | STUDYID, USUBJID, SVSTDTC, VISITNUM | sv.xpt | |
CM | Concomitant Medications | INTERVENTIONS | One record per recorded medication occurrence or constant-dosing interval per subject | Tabulation | STUDYID, USUBJID, CMSTDTC, CMENDTC, CMCAT, CMTRT, CMDOSTXT, CMDOSU, CMINDC, CMDOSFRQ | cm.xpt | |
EX | Exposure | INTERVENTIONS | One record per constant dosing interval per subject | Tabulation | STUDYID, USUBJID, EXSTDTC, EXENDTC, EXTRT, EXDOSE | ex.xpt | |
AE | Adverse Events | EVENTS | One record per adverse event per subject | Tabulation | STUDYID, USUBJID, AEDECOD, AESTDTC | ae.xpt | |
DS | Disposition | EVENTS | One record per disposition status or protocol milestone per subject | Tabulation | STUDYID, USUBJID, DSSTDY, DSSTDTC, DSCAT, DSDECOD | ds.xpt | |
MH | Medical History | EVENTS | One record per medical history event per subject | Tabulation | STUDYID, USUBJID, MHCAT, MHTERM, MHDTC, MHSTDTC | mh.xpt | |
DA | Drug Accountability | FINDINGS | One record per drug accountability finding per subject | Tabulation | STUDYID, USUBJID, DATESTCD, DADTC | da.xpt | |
EG | ECG Test Results | FINDINGS | One record per ECG observation per visit per subject | Tabulation | STUDYID, USUBJID, EGTESTCD, EGDTC, VISITNUM | eg.xpt | |
IE | Inclusion/Exclusion Criteria Not Met | FINDINGS | One record per inclusion/exclusion criterion not met per subject | Tabulation | STUDYID, USUBJID, IETESTCD | ie.xpt | |
LB | Laboratory Tests Results | FINDINGS | One record per analyte per visit per subject | Tabulation | STUDYID, USUBJID, LBCAT, LBMETHOD, LBTESTCD, LBDTC, VISITNUM | lb.xpt | |
PE | Physical Examination | FINDINGS | One record per body system or abnormality per visit per subject | Tabulation | STUDYID, USUBJID, PETESTCD, PEDTC, VISITNUM | pe.xpt | |
QSCG | Questionnaire-QSCG (Questionnaires) | FINDINGS | One record per questionnaire per question per visit per subject | Tabulation | STUDYID, USUBJID, QSCAT, QSTESTCD, QSDTC, VISITNUM | qscg.xpt | QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. |
QSCS | Questionnaire-QSCS (Questionnaires) | FINDINGS | One record per questionnaire per question per visit per subject | Tabulation | STUDYID, USUBJID, QSCAT, QSTESTCD, QSDTC, VISITNUM | qscs.xpt | QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. |
QSMM | Questionnaire-QSMM (Questionnaires) | FINDINGS | One record per questionnaire per question per visit per subject | Tabulation | STUDYID, USUBJID, QSCAT, QSTESTCD, QSDTC, VISITNUM | qsmm.xpt | QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. |
SC | Subject Characteristics | FINDINGS | One record per characteristic per subject | Tabulation | STUDYID, USUBJID, SCTESTCD | sc.xpt | |
VS | Vital Signs | FINDINGS | One record per vital sign measurement per visit per subject | Tabulation | STUDYID, USUBJID, VSTESTCD, VSDTC, VISITNUM, VSPOS | vs.xpt | |
RELREC | Related Records | RELATIONSHIP | One record per related record, group of records or dataset | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID | relrec.xpt | |
SUPPAE | Supplemental Qualifiers for AE (Adverse Events) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppae.xpt | |
SUPPCM | Supplemental Qualifiers for CM (Concomitant Medications) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppcm.xpt | |
SUPPDM | Supplemental Qualifiers for DM (Demographics) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppdm.xpt | |
SUPPEG | Supplemental Qualifiers for EG (ECG Test Results) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppeg.xpt | |
SUPPEX | Supplemental Qualifiers for EX (Exposure) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppex.xpt | |
SUPPLB | Supplemental Qualifiers for LB (Laboratory Tests Results) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | supplb.xpt | |
SUPPQSCG | Supplemental Qualifiers for QSCG (Questionnaires) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppqscg.xpt | |
SUPPQSCS | Supplemental Qualifiers for QSCS (Questionnaires) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppqscs.xpt | |
SUPPQSMM | Supplemental Qualifiers for QSMM (Questionnaires) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppqsmm.xpt | |
SUPPVS | Supplemental Qualifiers for VS (Vital Signs) | RELATIONSHIP | One record per IDVAR, IDVARVAL, and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppvs.xpt |
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Trial Arms (TA)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (TA)
| Assigned | ||
ARMCD | Planned Arm Code | 2 | text | 8 | Planned Arm Code
| Assigned | |
ARM | Description of Planned Arm | text | 20 | Description of Planned Arm
| Protocol | ||
TAETORD | Order of Element within Arm | 3 | integer | 1 | Assigned | ||
ETCD | Element Code | text | 8 | Assigned | |||
ELEMENT | Description of Element | text | 40 | Protocol | |||
TABRANCH | Branch | text | 35 | Protocol | |||
TATRANS | Transition Rule | text | 1 | Protocol | |||
EPOCH | Epoch | text | 30 | Protocol |
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Trial Elements (TE)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (TE)
| Assigned | ||
ETCD | Element Code | 2 | text | 8 | Assigned | ||
ELEMENT | Description of Element | text | 40 | Protocol | |||
TESTRL | Rule for Start of Element | text | 24 | Protocol | |||
TEDUR | Planned Duration of Element | text | 4 | Protocol |
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Trial Inclusion/Exclusion Criteria (TI)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (TI)
| Assigned | ||
IETESTCD | Incl/Excl Criterion Short Name | 2 | text | 6 | IE Test Codes [6 Terms] | Assigned | |
IETEST | Inclusion/Exclusion Criterion | text | 92 | IE Tests [6 Terms] | [CRF] Annotated Case Report Form 4 - 5 | ||
IECAT | Inclusion/Exclusion Category | text | 9 | [CRF] Annotated Case Report Form 4 - 5 |
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Trial Summary (TS)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (TS)
| Assigned | ||
TSSEQ | Sequence Number | 3 | integer | 1 | Derived | Sequential number identifying records within each TSPARM in the domain. | |
TSPARMCD | Trial Summary Parameter Short Name | 2 | text | 8 | Trial Summary Parameter Test Code [23 Terms] | Assigned | |
TSPARM | Trial Summary Parameter | text | 36 | Trial Summary Parameter Test Name [23 Terms] | Assigned | ||
TSVAL | Parameter Value | text | 57 | Protocol |
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Trial Visits (TV)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (TV)
| Assigned | ||
VISITNUM | Visit Number | 2 | integer | 2 | Assigned | ||
VISIT | Visit Name | text | 12 | Protocol | |||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
ARMCD | Planned Arm Code | 3 | text | 1 | Assigned | ||
TVSTRL | Visit Start Rule | text | 30 | Protocol |
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Demographics (DM)
Related dataset: Supplemental Qualifiers for DM (SUPPDM) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (DM)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
SUBJID | Subject Identifier for the Study | text | 6 | [CRF] Annotated Case Report Form 3 | |||
RFSTDTC | Subject Reference Start Date/Time | date | ISO8601 | Derived | RFSTDTC = first date/time of study drug, for safety subject. Null for screen failures. | ||
RFENDTC | Subject Reference End Date/Time | date | ISO8601 | Derived | RFENDTC = termination date, for safety subjects. Null for screen failures. | ||
SITEID | Study Site Identifier | text | 3 | [CRF] Annotated Case Report Form 3 | |||
BRTHDTC | Date/Time of Birth | date | ISO8601 | [CRF] Annotated Case Report Form 6 | |||
AGE | Age | integer | 2 | Derived | Age at Screening Date (Screening Date - Birth date). For the complete algorithm see the referenced external document. | ||
AGEU | Age Units | text | 5 | Assigned | Defaulted to YEARS | ||
SEX | Sex | text | 1 | Sex
| [CRF] Annotated Case Report Form 6 | ||
RACE | Race | text | 40 | Race [7 Terms] | [CRF] Annotated Case Report Form 6 | ||
ETHNIC | Ethnicity | text | 22 | Ethnic Group
| [CRF] Annotated Case Report Form 6 | ||
ARMCD | Planned Arm Code | text | 8 | Planned Arm Code
| Assigned | Assigned based on Randomization Number. See Note 2.1 | |
ARM | Description of Planned Arm | text | 20 | Description of Planned Arm
| Assigned | Assigned from TA.ARM based on ARMCD. | |
COUNTRY | Country | text | 3 | ISO3166 ISO3166 | Assigned |
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Subject Elements (SE)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (SE)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
SESEQ | Sequence Number | integer | 1 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
ETCD | Element Code | 6 | text | 7 | Assigned | ||
ELEMENT | Description of Element | text | 40 | Protocol | |||
SESTDTC | Start Date/Time of Element | 3 | date | ISO8601 | Derived | If Element = SCREEN, derived from SVSTDTC where VISIT = SCREENING or from DS where DSDECOD = 'INFORMED CONSENT', whichever is earliest. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT. For treatment Elements, derived from first EXSTDTC for the element. For the complete algorithm see the referenced external document. | |
SEENDTC | End Date/Time of Element | 4 | date | ISO8601 | Derived | If Element = SCREEN, derived from SVENDTC where VISIT = SCREENING. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT or from the latest EXENDTC from EX whichever is later. For treatment Elements, derived from last EXENDTC for the element. For the complete algorithm see the referenced external document. | |
TAETORD | Planned Order of Elements within Arm | 5 | integer | 1 | Protocol |
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Subject Visits (SV)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (SV)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
VISITNUM | Visit Number | 4 | integer | 2 | Derived | Derived from visit-based subject-level domains | |
VISIT | Visit Name | text | 8 | Derived | Derived from visit-based subject-level domains | ||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
SVSTDTC | Start Date/Time of Visit | 3 | date | ISO8601 | Derived | Derived from visit-based subject-level domains | |
SVENDTC | End Date/Time of Visit | date | ISO8601 | Derived | SVENDTC = SVSTDTC | ||
SVSTDY | Study Day of Start of Visit | integer | 3 | Derived | SVSTDY = SVSTDTC-RFSTDTC+1 if SVSTDTC is on or after RFSTDTC. SVSTDTC - RFSTDTC if SVSTDTC precedes RFSTDTC. |
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Concomitant Medications (CM)
Related dataset: Supplemental Qualifiers for CM (SUPPCM) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (CM)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
CMSEQ | Sequence Number | integer | 2 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
CMTRT | Reported Name of Drug, Med, or Therapy | 6 | text | 23 | [CRF] Annotated Case Report Form 9 22 | ||
CMMODIFY | Modified Reported Name | text | 23 | Assigned | |||
CMDECOD | Standardized Medication Name | text | 30 | Drug Dictionary WHODRUG 200204 | Assigned | ||
CMCAT | Category for Medication | 5 | text | 36 | Category for Medication
| [CRF] Annotated Case Report Form 9 22 | |
CMINDC | Indication | 9 | text | 27 | [CRF] Annotated Case Report Form 9 22 | ||
CMCLAS | Medication Class | text | 45 | Drug Dictionary WHODRUG 200204 | Assigned | Coded to ATC level 3 Term based on CMINDC | |
CMCLASCD | Medication Class Code | text | 3 | Drug Dictionary WHODRUG 200204 | Assigned | Coded to ATC level 3 Code based on CMINDC | |
CMDOSTXT | Dose Description | 7 | text | 4 | [CRF] Annotated Case Report Form 9 22 | ||
CMDOSU | Dose Units | 8 | text | 6 | Unit (CM) [13 Terms] | [CRF] Annotated Case Report Form 9 22 | |
CMDOSFRQ | Dosing Frequency per Interval | 10 | text | 5 | Frequency [9 Terms] | [CRF] Annotated Case Report Form 22 | |
CMROUTE | Route of Administration | text | 12 | Route of Administration [9 Terms] | [CRF] Annotated Case Report Form 22 | Free text from CRF mapped to CDISC CT | |
CMSTDTC | Start Date/Time of Medication | 3 | date | ISO8601 | [CRF] Annotated Case Report Form 9 22 | ||
CMENDTC | End Date/Time of Medication | 4 | date | ISO8601 | [CRF] Annotated Case Report Form 9 22 | ||
CMSTDY | Study Day of Start of Medication | integer | 6 | Derived | CMSTDY = CMSTDTC - RFSTDTC +1 if CMSTDTC is on or after RFSTDTC. CMSTDTC - RFSTDTC if CMSTDTC precedes RFSTDTC | ||
CMENDY | Study Day of End of Medication | integer | 4 | Derived | CMENDY = CMENDTC - RFSTDTC +1 if CMENDTC is on or after RFSTDTC. CMENDTC - RFSTDTC if CMENDTC precedes RFSTDTC | ||
CMENRF | End Relative to Reference Period | text | 6 | Relation to Reference Period (CMENRF)
| [CRF] Annotated Case Report Form 22 |
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Exposure (EX)
Related dataset: Supplemental Qualifiers for EX (SUPPEX) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (EX)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
EXSEQ | Sequence Number | integer | 1 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
EXTRT | Name of Actual Treatment | 5 | text | 20 | Treatment
| Derived | Derived from ARM, ARMCD |
EXDOSE | Dose per Administration | 6 | integer | 2 | Derived | If ARMCD=WONDER10 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 10. If ARMCD=WONDER20 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 20. If ARMCD=PLACEBO then EXDOSE = 0. | |
EXDOSU | Dose Units | text | 2 | Derived | Derived from ARM, ARMCD - equal to mg | ||
EXDOSFRM | Dose Form | text | 7 | Pharmaceutical Dosage Form
| [CRF] Annotated Case Report Form 20 | ||
EXSTDTC | Start Date/Time of Treatment | 3 | date | ISO8601 | [CRF] Annotated Case Report Form 20 | ||
EXENDTC | End Date/Time of Treatment | 4 | date | ISO8601 | [CRF] Annotated Case Report Form 20 | ||
EXSTDY | Study Day of Start of Treatment | integer | 2 | Derived | EXSTDY = EXSTDTC - RFSTDTC+1 if EXSTDTC is on or after RFSTDTC. EXSTDTC - RFSTDTC if EXSTDTC precedes RFSTDTC. | ||
EXENDY | Study Day of End of Treatment | integer | 2 | Derived | EXENDY = EXENDTC-RFSTDTC+1 if EXENDTC is on or after RFSTDTC. EXENDTC - RFSTDTC if EXENDTC precedes RFSTDTC. |
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Adverse Events (AE)
Related dataset: Supplemental Qualifiers for AE (SUPPAE) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (AE)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
AESEQ | Sequence Number | integer | 1 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
AESPID | Sponsor-Defined Identifier | text | 4 | [CRF] Annotated Case Report Form 21 | |||
AETERM | Reported Term for the Adverse Event | text | 25 | [CRF] Annotated Case Report Form 21 | |||
AEMODIFY | Modified Reported Term | text | 9 | Assigned | |||
AEDECOD | Dictionary-Derived Term | 3 | text | 18 | Adverse Event Dictionary MEDDRA 8.0 | Assigned | |
AEBODSYS | Body System or Organ Class | text | 52 | Adverse Event Dictionary MEDDRA 8.0 | Assigned | ||
AESEV | Severity/Intensity | text | 8 | Severity/Intensity Scale for Adverse Events
| [CRF] Annotated Case Report Form 21 | ||
AESER | Serious Event | text | 1 | No Yes Response Subset
| [CRF] Annotated Case Report Form 21 | ||
AEACN | Action Taken with Study Treatment | text | 30 | Action Taken with Study Treatment
| [CRF] Annotated Case Report Form 21 | ||
AEREL | Causality | text | 16 | Causality
| [CRF] Annotated Case Report Form 21 | ||
AESTDTC | Start Date/Time of Adverse Event | 4 | date | ISO8601 | [CRF] Annotated Case Report Form 21 | ||
AEENDTC | End Date/Time of Adverse Event | date | ISO8601 | [CRF] Annotated Case Report Form 21 | |||
AESTDY | Study Day of Start of Adverse Event | integer | 3 | Derived | AESTDY = AESTDTC - RFSTDTC+1 if AESTDTC is on or after RFSTDTC. AESTDTC - RFSTDTC if AESTDTC precedes RFSTDTC | ||
AEENDY | Study Day of End of Adverse Event | integer | 3 | Derived | AEENDY = AEENDTC -RFSTDTC+1 if AEENDTC is on or after RFSTDTC. AEENDTC - RFSTDTC if AEENDTC precedes RFSTDTC | ||
AEENRF | End Relative to Reference Period | text | 5 | Relation to Reference Period (AEENRF)
| [CRF] Annotated Case Report Form 21 |
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Disposition (DS)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (DS)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
DSSEQ | Sequence Number | integer | 1 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
DSTERM | Reported Term for the Disposition Event | text | 34 | Reported Term for the Disposition Record [11 Terms] | [CRF] Annotated Case Report Form 6 16 18 | ||
DSDECOD | Standardized Disposition Term | 6 | text | 21 | Completion/Reason for Non-Completion [10 Terms] | [CRF] Annotated Case Report Form 6 16 18 | CRF controlled terminology was mapped to match CDISC controlled terminology. |
DSCAT | Category for Disposition Event | 5 | text | 18 | Category for Disposition Event
| Assigned | |
EPOCH | Epoch | text | 9 | Epoch
| Assigned | ||
DSSTDTC | Start Date/Time of Disposition Event | 4 | date | ISO8601 | [CRF] Annotated Case Report Form 6 16 18 | ||
DSSTDY | Study Day of Start of Disposition Event | 3 | integer | 3 | Derived | DSSTDY = DSSTDTC - RFSTDTC+1 if DSSTDTC is on or after RFSTDTC. DSSTDTC - RFSTDTC if DSSTDTC precedes RFSTDTC. Null if RFSTDTC is Null. |
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Medical History (MH)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (MH)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
MHSEQ | Sequence Number | integer | 1 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
MHTERM | Reported Term for the Medical History | 4 | text | 169 | [CRF] Annotated Case Report Form 7 - 8 | ||
MHCAT | Category for Medical History | 3 | text | 28 | Category for Medical History
| [CRF] Annotated Case Report Form 7 - 8 | |
MHPRESP | Medical History Event Pre-Specified | text | 2 | No Yes Response Subset
| Assigned | ||
MHOCCUR | Medical History Occurrence | text | 2 | No Yes Response Subset
| Assigned | ||
MHBODSYS | Body System or Organ Class | text | 23 | Body System or Organ Class
| Assigned | Assigned for Medical History but not Psychiatric History | |
MHDTC | Date/Time of History Collection | 5 | date | ISO8601 | [CRF] Annotated Case Report Form 7 - 8 | ||
MHSTDTC | Start Date/Time of Medical History Event | 6 | date | ISO8601 | [CRF] Annotated Case Report Form 7 - 8 | ||
MHENRF | End Relative to Reference Period | text | 30 | Relation to Reference Period (MHENRF)
| [CRF] Annotated Case Report Form 8 | CRF controlled terminology was mapped to match CDISC controlled terminology. |
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Drug Accountability (DA)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (DA)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
DASEQ | Sequence Number | integer | 1 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
DATESTCD | Short Name of Accountability Assessment | 3 | text | 7 | Drug Accountability Test Code
| Assigned | |
DATEST | Name of Accountability Assessment | text | 25 | Drug Accountability Test Name
| [CRF] Annotated Case Report Form 19 | ||
DAORRES | Assessment Result in Original Units | text | 2 | [CRF] Annotated Case Report Form 19 | |||
DAORRESU | Original Units | text | 7 | [CRF] Annotated Case Report Form 19 | |||
DASTRESC | Assessment Result in Std Format | text | 2 | Derived | DASTRESC = DAORRES | ||
DASTRESN | Numeric Result/Finding in Standard Units | integer | 2 | Derived | DASTRESN = numeric value of DAORRES, when DAORRES contains numeric data. | ||
DASTRESU | Assessment Standard Units | text | 7 | Derived | DASTRESU = DAORRESU | ||
VISITNUM | Visit Number | integer | 2 | Derived | Derived from DADTC and SVSTDTC. | ||
VISIT | Visit Name | text | 8 | Assigned | |||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
DADTC | Date/Time of Accountability Assessment | 4 | date | ISO8601 | [CRF] Annotated Case Report Form 19 | ||
DADY | Study Day of Accountability Assessment | integer | 3 | Derived | DADY = DADTC - RFSTDTC+1 if DADTC is on or after RFSTDTC. DADTC - RFSTDTC if DADTC precedes RFSTDTC. |
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ECG Test Results (EG)
Related dataset: Supplemental Qualifiers for EG (SUPPEG) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (EG)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
EGSEQ | Sequence Number | integer | 2 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
EGSPID | Sponsor-Defined Identifier | text | 6 | Assigned | ECG parameter ordering variable | ||
EGTESTCD | ECG Test or Examination Short Name | 3 | text | 6 | ECG Test Code [7 Terms] | Assigned | |
EGTEST | ECG Test or Examination Name | text | 40 | ECG Test Name [7 Terms] | [CRF] Annotated Case Report Form 12 | ||
EGPOS | ECG Position of Subject | text | 6 | Protocol | Equal to SUPINE | ||
EGORRES | Result or Finding in Original Units | text | 15 | [CRF] Annotated Case Report Form 12 | |||
EGORRESU | Original Units | text | 4 | Unit (EGRESU)
| [CRF] Annotated Case Report Form 12 | ||
EGSTRESC | Character Result/Finding in Std Format | text | 15 | Derived | Data collected in non-standard units is converted using standard conversion factors to standard units. | ||
EGSTRESN | Numeric Result/Finding in Standard Units | float | 5 | Derived | EGSTRESN = numeric value of EGSTRESC, when EGSTRESC contains numeric data. | ||
EGSTRESU | Standard Units | text | 9 | Unit (EGRESU)
| Assigned | ||
EGBLFL | Baseline Flag | text | 1 | No Yes Response Subset
| Derived | Safety subjects only: EGBLFL = "Y" for last record with non Null EGORRES on or before the first dose date (RFSTDTC). Null otherwise | |
EGDRVFL | Derived Flag | text | 1 | No Yes Response Subset
| Derived | EGDRVFL = "Y" for derived EGTESTCDs QTCB and QTCF. Null otherwise. | |
EGEVAL | Evaluator | text | 12 | Assigned | Equal to INVESTIGATOR for CRF data | ||
VISITNUM | Visit Number | 5 | integer | 2 | Assigned | Assigned from the TV domain based on the VISIT | |
VISIT | Visit Name | text | 7 | Assigned | |||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
EGDTC | Date/Time of ECG | 4 | date | ISO8601 | [CRF] Annotated Case Report Form 12 | ||
EGDY | Study Day of ECG | integer | 3 | Derived | EGDY = EGDTC-RFSTDTC+1 if EGDTC is on or after RFTSDTC. EGDTC - RFSTDTC if EGDTC precedes RFSTDTC. |
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Inclusion/Exclusion Criteria Not Met (IE)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (IE)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IESEQ | Sequence Number | integer | 1 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
IETESTCD | Inclusion/Exclusion Criterion Short Name | 3 | text | 6 | IE Test Codes [6 Terms] | Assigned | |
IETEST | Inclusion/Exclusion Criterion | text | 54 | IE Tests [6 Terms] | [CRF] Annotated Case Report Form 4 - 5 | ||
IECAT | Inclusion/Exclusion Category | text | 9 | [CRF] Annotated Case Report Form 4 - 5 | |||
IEORRES | I/E Criterion Original Result | text | 1 | [CRF] Annotated Case Report Form 4 - 5 | |||
IESTRESC | I/E Criterion Result in Std Format | text | 1 | Derived | IESTRESC = IEORRES | ||
VISITNUM | Visit Number | integer | 1 | Assigned | Assigned from the TV domain based on the VISIT | ||
VISIT | Visit Name | text | 6 | Assigned | |||
IEDTC | Date/Time of Collection | date | ISO8601 | [CRF] Annotated Case Report Form 4 - 5 |
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Laboratory Tests Results (LB)
Related dataset: Supplemental Qualifiers for LB (SUPPLB) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (LB)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
LBSEQ | Sequence Number | integer | 2 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
LBREFID | Specimen ID | text | 7 | eDT | Accession number | ||
LBTESTCD | Lab Test or Examination Short Name | 5 | text | 7 | Laboratory Test Code [10 Terms] | Assigned | |
LBTEST | Lab Test or Examination Name | text | 22 | Laboratory Test Name [10 Terms] | eDT | ||
LBCAT | Category for Lab Test | 3 | text | 10 | eDT | ||
LBORRES | Result or Finding in Original Units | text | 8 | eDT | |||
LBORRESU | Original Units | text | 7 | Unit (LBRESU) [6 Terms] | eDT | ||
LBORNRLO | Reference Range Lower Limit in Orig Unit | text | 8 | eDT | |||
LBORNRHI | Reference Range Upper Limit in Orig Unit | text | 8 | eDT | |||
LBSTRESC | Character Result/Finding in Std Format | text | 8 | eDT | |||
LBSTRESN | Numeric Result/Finding in Standard Units | float | 5 | eDT | |||
LBSTRESU | Standard Units | text | 7 | eDT | |||
LBSTNRLO | Reference Range Lower Limit-Std Units | float | 4 | eDT | |||
LBSTNRHI | Reference Range Upper Limit-Std Units | float | 4 | eDT | |||
LBSTNRC | Reference Range for Char Rslt-Std Units | text | 19 | eDT | |||
LBNRIND | Reference Range Indicator | text | 20 | Reference Range Indicator
| Derived | Reference Range Indicator based upon standard results and ranges. | |
LBSPEC | Specimen Type | text | 5 | Specimen Type
| eDT | ||
LBMETHOD | Method of Test or Examination | 4 | text | 8 | Method
| eDT | |
LBBLFL | Baseline Flag | text | 1 | No Yes Response Subset
| Derived | Safety subjects only: LBBLFL = "Y" for last record with non Null LBORRES on or before the first dose date (RFSTDTC). Null otherwise. | |
LBFAST | Fasting Status | text | 1 | No Yes Response Subset
| eDT | ||
VISITNUM | Visit Number | 7 | integer | 2 | eDT | ||
VISIT | Visit Name | text | 7 | eDT | |||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
LBDTC | Date/Time of Specimen Collection | 6 | datetime | ISO8601 | eDT | ||
LBDY | Study Day of Specimen Collection | integer | 3 | Derived | LBDY = LBDTC-RFSTDTC+1 if LBDTC is on or after RFSTDTC. LBDTC - RFSTDTC if LBDTC precedes RFSTDTC. |
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Physical Examination (PE)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (PE)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
PESEQ | Sequence Number | integer | 2 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
PETESTCD | Body System Examined Short Name | 3 | text | 4 | PE Test Codes [9 Terms] | Assigned | |
PETEST | Body System Examined | text | 29 | PE Tests [9 Terms] | [CRF] Annotated Case Report Form 10 | ||
PEORRES | Verbatim Examination Finding | text | 36 | [CRF] Annotated Case Report Form 10 | |||
PESTRESC | Character Result/Finding in Std Format | text | 26 | Derived | PESTRESC = PEORRES | ||
VISITNUM | Visit Number | 5 | integer | 2 | Assigned | Assigned from the TV domain based on the VISIT | |
VISIT | Visit Name | text | 7 | Assigned | |||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
PEDTC | Date/Time of Examination | 4 | date | ISO8601 | [CRF] Annotated Case Report Form 10 | ||
PEDY | Study Day of Examination | integer | 3 | Derived | PEDY = PEDTC-RFSTDTC+1 if PEDTC is on or after RFSTDTC. PEDTC - RFSTDTC if PEDTC precedes RFSTDTC. |
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Questionnaire-QSCG (QSCG)
Related dataset: Supplemental Qualifiers for QSCG (SUPPQSCG) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (QS)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
QSSEQ | Sequence Number | integer | 3 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
QSTESTCD | Question Short Name | 4 | text | 7 | QS Test Codes [28 Terms] | Assigned | |
QSTEST | Question Name | text | 37 | QS Tests [27 Terms] | [CRF] Annotated Case Report Form 17 | ||
QSCAT | Category of Question | 3 | text | 50 | [CRF] Annotated Case Report Form 17 | ||
QSORRES | Finding in Original Units | text | 20 | [CRF] Annotated Case Report Form 17 | |||
QSSTRESC | Character Result/Finding in Std Format | text | 2 | Derived | If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data. | ||
QSSTRESN | Numeric Finding in Standard Units | integer | 2 | Derived | When QSORRES is numeric then QSSTRESN equal to numeric result | ||
VISITNUM | Visit Number | 6 | integer | 2 | Assigned | Assigned from the TV domain based on the VISIT | |
VISIT | Visit Name | text | 8 | Assigned | |||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
QSDTC | Date/Time of Finding | 5 | date | ISO8601 | [CRF] Annotated Case Report Form 17 | ||
QSDY | Study Day of Finding | integer | 3 | Derived | QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC. |
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Questionnaire-QSCS (QSCS)
Related dataset: Supplemental Qualifiers for QSCS (SUPPQSCS) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (QS)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
QSSEQ | Sequence Number | integer | 3 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
QSTESTCD | Question Short Name | 4 | text | 7 | QS Test Codes [28 Terms] | Assigned | |
QSTEST | Question Name | text | 37 | QS Tests [27 Terms] | [CRF] Annotated Case Report Form 17 | ||
QSCAT | Category of Question | 3 | text | 50 | [CRF] Annotated Case Report Form 17 | ||
QSSCAT | Subcategory for Question | text | 40 | [CRF] Annotated Case Report Form 14 - 15 | |||
QSORRES | Finding in Original Units | text | 20 | [CRF] Annotated Case Report Form 17 | |||
QSSTRESC | Character Result/Finding in Std Format | text | 2 | Derived | If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data. | ||
QSSTRESN | Numeric Finding in Standard Units | integer | 2 | Derived | When QSORRES is numeric then QSSTRESN equal to numeric result | ||
QSBLFL | Baseline Flag | text | 1 | No Yes Response Subset
| Derived | Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise. | |
VISITNUM | Visit Number | 6 | integer | 2 | Assigned | Assigned from the TV domain based on the VISIT | |
VISIT | Visit Name | text | 8 | Assigned | |||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
QSDTC | Date/Time of Finding | 5 | date | ISO8601 | [CRF] Annotated Case Report Form 17 | ||
QSDY | Study Day of Finding | integer | 3 | Derived | QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC. | ||
QSEVLINT | Evaluation Interval | text | 20 | [CRF] Annotated Case Report Form 14 |
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Questionnaire-QSMM (QSMM)
Related dataset: Supplemental Qualifiers for QSMM (SUPPQSMM) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (QS)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
QSSEQ | Sequence Number | integer | 3 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
QSTESTCD | Question Short Name | 4 | text | 7 | QS Test Codes [28 Terms] | Assigned | |
QSTEST | Question Name | text | 37 | QS Tests [27 Terms] | [CRF] Annotated Case Report Form 17 | ||
QSCAT | Category of Question | 3 | text | 50 | [CRF] Annotated Case Report Form 17 | ||
QSORRES | Finding in Original Units | text | 20 | [CRF] Annotated Case Report Form 17 | |||
QSSTRESC | Character Result/Finding in Std Format | text | 2 | Derived | If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data. | ||
QSSTRESN | Numeric Finding in Standard Units | integer | 2 | Derived | When QSORRES is numeric then QSSTRESN equal to numeric result | ||
QSBLFL | Baseline Flag | text | 1 | No Yes Response Subset
| Derived | Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise. | |
VISITNUM | Visit Number | 6 | integer | 2 | Assigned | Assigned from the TV domain based on the VISIT | |
VISIT | Visit Name | text | 8 | Assigned | |||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
QSDTC | Date/Time of Finding | 5 | date | ISO8601 | [CRF] Annotated Case Report Form 17 | ||
QSDY | Study Day of Finding | integer | 3 | Derived | QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC. |
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Subject Characteristics (SC)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (SC)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
SCSEQ | Sequence Number | integer | 1 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
SCTESTCD | Subject Characteristic Short Name | 3 | text | 8 | Subject Characteristic Code (SCTESTCD)
| Assigned | |
SCTEST | Subject Characteristic | text | 16 | SC Tests
| [CRF] Annotated Case Report Form 6 | ||
SCORRES | Result or Finding in Original Units | text | 24 | [CRF] Annotated Case Report Form 3 6 | |||
SCSTRESC | Character Result/Finding in Std Format | text | 24 | Derived | SCSTRESC = SCORRES | ||
SCDTC | Date/Time of Collection | date | ISO8601 | [CRF] Annotated Case Report Form 6 | |||
SCDY | Study Day of Examination | integer | 3 | Derived | SCDY = SCDTC-RFSTDTC+1 if SCDTC is on or after RFSTDTC. SCDTC - RFSTDTC if SCDTC precedes RFSTDTC. |
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Vital Signs (VS)
Related dataset: Supplemental Qualifiers for VS (SUPPVS) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
DOMAIN | Domain Abbreviation | text | 2 | Domain Abbreviation (VS)
| Assigned | ||
USUBJID | Unique Subject Identifier | 2 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
VSSEQ | Sequence Number | integer | 2 | Derived | Sequential number identifying records within each USUBJID in the domain. | ||
VSTESTCD | Vital Signs Test Short Name | 3 | text | 20 | Vital Signs Test Code [6 Terms] | Assigned | |
VSTEST | Vital Signs Test Name | text | 24 | Vital Signs Test Name [6 Terms] | [CRF] Annotated Case Report Form 11 | ||
VSPOS | Vital Signs Position of Subject | 6 | text | 7 | [CRF] Annotated Case Report Form 11 | ||
VSORRES | Result or Finding in Original Units | text | 30 | [CRF] Annotated Case Report Form 11 | |||
VSORRESU | Original Units | text | 20 | [CRF] Annotated Case Report Form 11 | |||
VSSTRESC | Character Result/Finding in Std Format | text | 30 | Derived | Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm). | ||
VSSTRESN | Numeric Result/Finding in Standard Units | float | 5 | Derived | VSSTRESN = numeric value of VSSTRESC, when VSSTRESC contains numeric data. | ||
VSSTRESU | Standard Units | text | 9 | Units for Vital Signs Results
| Assigned | Standard units consistent with CDISC controlled terminology | |
VSBLFL | Baseline Flag | text | 1 | No Yes Response Subset
| Derived | Safety subjects only: VSBLFL = "Y" for last record with non Null VSORRES on or before the first dose date (RFSTDTC). Null otherwise. | |
VISITNUM | Visit Number | 5 | integer | 2 | Assigned | Assigned from the TV domain based on the VISIT | |
VISIT | Visit Name | text | 8 | Assigned | |||
VISITDY | Planned Study Day of Visit | integer | 3 | Protocol | |||
VSDTC | Date/Time of Measurements | 4 | date | ISO8601 | [CRF] Annotated Case Report Form 11 | ||
VSDY | Study Day of Vital Signs | integer | 3 | Derived | VSDY = VSDTC-RFSTDTC+1 if VSDTC is on or after RFSTDTC. VSDTC - RFSTDTC if VSDTC precedes RFSTDTC. |
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Related Records (RELREC)
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 8 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 2 | Assigned | Value of identifying variable described in IDVAR. | |
RELTYPE | Relationship Type | text | 4 | Assigned | All values are null since this is used only when identifying a dataset-level relationship. | ||
RELID | Relationship Identifier | 6 | text | 10 | Derived | All records for the same USUBJID with the same RELID are considered related. |
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Supplemental Qualifiers for AE (SUPPAE)
Related dataset: Adverse Events (AE) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 5 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 1 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 7 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 30 | Assigned | |||
QVAL | Data Value | text | 60 | ||||
QORIG | Origin | text | 7 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: Adverse Events (AE) |
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Supplemental Qualifiers for CM (SUPPCM)
Related dataset: Concomitant Medications (CM) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 5 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 2 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 8 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 26 | Assigned | |||
QVAL | Data Value | text | 43 | ||||
QORIG | Origin | text | 10 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: Concomitant Medications (CM) |
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Supplemental Qualifiers for DM (SUPPDM)
Related dataset: Demographics (DM) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 1 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 1 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 8 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 26 | Assigned | |||
QVAL | Data Value | text | 30 | ||||
QORIG | Origin | text | 11 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: Demographics (DM) |
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Supplemental Qualifiers for EG (SUPPEG)
Related dataset: ECG Test Results (EG) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 5 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 2 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 7 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 36 | Assigned | |||
QVAL | Data Value | text | 2 | ||||
QORIG | Origin | text | 7 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: ECG Test Results (EG) |
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Supplemental Qualifiers for EX (SUPPEX)
Related dataset: Exposure (EX) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 5 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 1 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 4 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 25 | Assigned | |||
QVAL | Data Value | text | 2 | ||||
QORIG | Origin | text | 11 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: Exposure (EX) |
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Supplemental Qualifiers for LB (SUPPLB)
Related dataset: Laboratory Tests Results (LB) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 5 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 2 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 7 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 36 | Assigned | |||
QVAL | Data Value | text | 2 | ||||
QORIG | Origin | text | 7 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: Laboratory Tests Results (LB) |
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Supplemental Qualifiers for QSCG (SUPPQSCG)
Related dataset: Questionnaire-QSCG (QSCG) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 5 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 50 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 7 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 36 | Assigned | |||
QVAL | Data Value | text | 3 | ||||
QORIG | Origin | text | 7 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: Questionnaire-QSCG (QSCG) |
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Supplemental Qualifiers for QSCS (SUPPQSCS)
Related dataset: Questionnaire-QSCS (QSCS) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 5 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 50 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 7 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 36 | Assigned | |||
QVAL | Data Value | text | 3 | ||||
QORIG | Origin | text | 7 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: Questionnaire-QSCS (QSCS) |
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Supplemental Qualifiers for QSMM (SUPPQSMM)
Related dataset: Questionnaire-QSMM (QSMM) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 5 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 50 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 7 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 36 | Assigned | |||
QVAL | Data Value | text | 3 | ||||
QORIG | Origin | text | 7 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: Questionnaire-QSMM (QSMM) |
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Supplemental Qualifiers for VS (SUPPVS)
Related dataset: Vital Signs (VS) | |||||||
Variable | Label | Key | Type | Length | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|
STUDYID | Study Identifier | 1 | text | 7 | Protocol | ||
RDOMAIN | Related Domain Abbreviation | 2 | text | 2 | Derived | Domain abbreviation from where data originated. | |
USUBJID | Unique Subject Identifier | 3 | text | 14 | Derived | Concatenation of STUDYID and SUBJID | |
IDVAR | Identifying Variable | 4 | text | 5 | Assigned | Name of the variables for the related records. | |
IDVARVAL | Identifying Variable Value | 5 | text | 2 | Assigned | Value of identifying variable described in IDVAR. | |
QNAM | Qualifier Variable Name | 6 | text | 7 | Assigned | ||
QLABEL | Qualifier Variable Label | text | 36 | Assigned | |||
QVAL | Data Value | text | 2 | ||||
QORIG | Origin | text | 7 | Assigned | |||
QEVAL | Evaluator | text | 30 | Assigned | |||
Related dataset: Vital Signs (VS) |
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Value Level Metadata
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
DAORRES | DATESTCD = "DISPAMT" (Dispensed Amount) | integer | 2 | [CRF] Annotated Case Report Form 19 | ||
DAORRES | DATESTCD = "RETAMT" (Returned Amount) | integer | 2 | [CRF] Annotated Case Report Form 19 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
EGORRES | EGTESTCD = "INTP" (Interpretation) | text | 8 | Interpretation: Original Results
| [CRF] Annotated Case Report Form 12 | |
EGORRES | EGTESTCD = "PRMEAN" (Summary (Mean) PR Duration) | integer | 3 | [CRF] Annotated Case Report Form 12 | ||
EGORRES | EGTESTCD = "QRSDUR" (Summary (Mean) QRS Duration) | integer | 3 | [CRF] Annotated Case Report Form 12 | ||
EGORRES | EGTESTCD = "QTMEAN" (Summary (Mean) QT Duration) | integer | 3 | [CRF] Annotated Case Report Form 12 | ||
EGORRES | EGTESTCD = "VRMEAN" (Summary (Mean) Ventricular Rate) | integer | 2 | [CRF] Annotated Case Report Form 12 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
EGSTRESC | EGTESTCD = "QTCB" (QTcB - Bazett's Correction Formula) | float | 5.1 | Derived | QTcB = QT interval / square root of (60 / heart rate). For the complete algorithm see the referenced external document. | |
EGSTRESC | EGTESTCD = "QTCF" (QTcF - Fridericia's Correction Formula) | float | 5.1 | Derived | QTcF = QT interval / cubic root of (60 / heart rate). For the complete algorithm see the referenced external document. |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
IEORRES | IETESTCD = "EXCL01" (Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment) | text | 200 | No Yes Response
| [CRF] Annotated Case Report Form 5 | |
IEORRES | IETESTCD = "EXCL02" (Is unable or unwilling to undergo multiple venipunctures) | text | 200 | No Yes Response
| [CRF] Annotated Case Report Form 5 | |
IEORRES | IETESTCD = "EXCL03" (Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years) | text | 200 | No Yes Response
| [CRF] Annotated Case Report Form 5 | |
IEORRES | IETESTCD = "INCL01" (Is age 18 - 85) | text | 200 | No Yes Response
| [CRF] Annotated Case Report Form 4 | |
IEORRES | IETESTCD = "INCL02" (Has Xyz disease of at least 10 weeks duration confirmed by biopsy) | text | 200 | No Yes Response
| [CRF] Annotated Case Report Form 4 | |
IEORRES | IETESTCD = "INCL03" (Did not respond to a standard course of medication Abc) | text | 200 | No Yes Response
| [CRF] Annotated Case Report Form 4 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
LBORRES | LBTESTCD = "BILI" (Bilirubin) and LBCAT = "CHEMISTRY" and LBSPEC = "BLOOD" | float | 3 | eDT | ||
LBORRES | LBTESTCD = "BUN" (Blood Urea Nitrogen) and LBCAT = "CHEMISTRY" and LBSPEC = "BLOOD" | float | 4 | eDT | ||
LBORRES | LBTESTCD = "GLUC" (Glucose) and LBCAT = "CHEMISTRY" and LBSPEC = "BLOOD" | float | 3 | eDT | ||
LBORRES | LBTESTCD = "GLUC" (Glucose) and LBCAT = "URINALYSIS" and LBSPEC = "URINE" and LBMETHOD = "DIPSTICK" | text | 8 | eDT | ||
LBORRES | LBTESTCD = "GLUC" (Glucose) and LBCAT = "URINALYSIS" and LBSPEC = "URINE" and LBMETHOD = "QUANT" | text | 8 | eDT | ||
LBORRES | LBTESTCD = "HCT" (Hematocrit) and LBCAT = "HEMATOLOGY" and LBSPEC = "BLOOD" | float | 4 | eDT | ||
LBORRES | LBTESTCD = "HGB" (Hemoglobin) and LBCAT = "HEMATOLOGY" and LBSPEC = "BLOOD" | float | 4 | eDT | ||
LBORRES | LBTESTCD = "LYM" (Lymphocytes) and LBCAT = "HEMATOLOGY" and LBSPEC = "BLOOD" | float | 4 | eDT | ||
LBORRES | LBTESTCD = "OCCBLD" (Occult Blood) and LBCAT = "URINALYSIS" and LBSPEC = "URINE" | text | 8 | eDT | ||
LBORRES | LBTESTCD = "PH" (pH) and LBCAT = "URINALYSIS" and LBSPEC = "URINE" | float | 3 | eDT | ||
LBORRES | LBTESTCD = "VITB12" (Vitamin B12) and LBCAT = "CHEMISTRY" and LBSPEC = "SERUM" | integer | 3 | eDT | ||
LBORRES | LBTESTCD = "VITB9" (Vitamin B9) and LBCAT = "CHEMISTRY" and LBSPEC = "BLOOD" | float | 5 | eDT |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
PEORRES | PETESTCD = "PE01" (Appearance/Skin) | text | 16 | [CRF] Annotated Case Report Form 10 | ||
PEORRES | PETESTCD = "PE02" (Head/Neck (Including Thyroid)) | text | 6 | [CRF] Annotated Case Report Form 10 | ||
PEORRES | PETESTCD = "PE03" (Eyes-Ears-Nose-Throat) | text | 13 | [CRF] Annotated Case Report Form 10 | ||
PEORRES | PETESTCD = "PE04" (Cardiovascular) | text | 20 | [CRF] Annotated Case Report Form 10 | ||
PEORRES | PETESTCD = "PE05" (Pulmonary) | text | 6 | [CRF] Annotated Case Report Form 10 | ||
PEORRES | PETESTCD = "PE06" (Abdomen) | text | 6 | [CRF] Annotated Case Report Form 10 | ||
PEORRES | PETESTCD = "PE07" (Neurological) | text | 26 | [CRF] Annotated Case Report Form 10 | ||
PEORRES | PETESTCD = "PE08" (Musculoskeletal) | text | 6 | [CRF] Annotated Case Report Form 10 | ||
PEORRES | PETESTCD = "PE09" (Other) | text | 19 | [CRF] Annotated Case Report Form 10 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QSORRES | QSTESTCD = "CGIGLOB" (Global Improvement) | integer | 1 | Global Improvement [7 Terms] | [CRF] Annotated Case Report Form 17 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QSORRES | QSTESTCD = "CSDD01" (Anxiety) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 14 | |
QSORRES | QSTESTCD = "CSDD02" (Sadness) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 14 | |
QSORRES | QSTESTCD = "CSDD03" (Lack of Reactivity to Pleasant Events) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 14 | |
QSORRES | QSTESTCD = "CSDD04" (Irritability) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 14 | |
QSORRES | QSTESTCD = "CSDD05" (Agitation) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 14 | |
QSORRES | QSTESTCD = "CSDD06" (Retardation) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 14 | |
QSORRES | QSTESTCD = "CSDD07" (Multiple Physical Complaints) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 14 | |
QSORRES | QSTESTCD = "CSDD08" (Loss of Interest) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 14 | |
QSORRES | QSTESTCD = "CSDD09" (Appetite Loss) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD10" (Weight Loss) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD11" (Lack of Energy) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD12" (Diurnal Variation of Mood) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD13" (Difficulty Falling Asleep) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD14" (Multiple Awakenings During Sleep) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD15" (Early Morning Awakening) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD16" (Suicide) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD17" (Poor Self-Esteem) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD18" (Pessimism) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDD19" (Mood-Congruent Delusions) | integer | 1 | CUE_EXPF_X
| [CRF] Annotated Case Report Form 15 | |
QSORRES | QSTESTCD = "CSDDTOT" (Total Score) | integer | 2 | [CRF] Annotated Case Report Form 15 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QSORRES | QSTESTCD = "MMSEA1" (Orientation time score) | integer | 1 | [CRF] Annotated Case Report Form 13 | ||
QSORRES | QSTESTCD = "MMSEA2" (Orientation place score) | integer | 1 | [CRF] Annotated Case Report Form 13 | ||
QSORRES | QSTESTCD = "MMSEB" (Registration) | integer | 1 | [CRF] Annotated Case Report Form 13 | ||
QSORRES | QSTESTCD = "MMSEC" (Attention and Calculation) | integer | 1 | [CRF] Annotated Case Report Form 13 | ||
QSORRES | QSTESTCD = "MMSED" (Recall) | integer | 1 | [CRF] Annotated Case Report Form 13 | ||
QSORRES | QSTESTCD = "MMSEET" (Language) | integer | 1 | [CRF] Annotated Case Report Form 13 | ||
QSORRES | QSTESTCD = "MMSETOT" (Total Score) | integer | 2 | [CRF] Annotated Case Report Form 13 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
SCORRES | SCTESTCD = "EDLEVEL" (Education Level) | text | 24 | [CRF] Annotated Case Report Form 6 | ||
SCORRES | SCTESTCD = "MARISTAT" (Marital Status) | text | 17 | Marital Status [6 Terms] | [CRF] Annotated Case Report Form 6 | |
SCORRES | SCTESTCD = "SUBJINIT" (Subject Initials) | text | 3 | [CRF] Annotated Case Report Form 3 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "AETRTEM" (Treatment Emergent Flag) | text | 1 | No Yes Response Subset
| Derived | AETRTEM = "Y" if Adverse Event was not present prior to the RFSTDTC, or it was present prior to the RFSTDTC but increased in severity during the treatment period. Null otherwise. |
QVAL | QNAM = "HLGT" (High Level Group Term) | text | 52 | Adverse Event Dictionary MEDDRA 8.0 | Assigned | |
QVAL | QNAM = "HLT" (High Level Term) | text | 60 | Adverse Event Dictionary MEDDRA 8.0 | Assigned | |
QVAL | QNAM = "LLT" (Lowest Level Term) | text | 18 | Adverse Event Dictionary MEDDRA 8.0 | Assigned |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "ATC4CODE" (WHODRUG ATC Level 4 Code) | text | 5 | Drug Dictionary WHODRUG 200204 | Assigned | |
QVAL | QNAM = "ATC4TERM" (ATC4 Drug Class Term) | text | 43 | Drug Dictionary WHODRUG 200204 | Assigned | |
QVAL | QNAM = "CPREFCD" (WHODRUG Drug Code) | text | 11 | Drug Dictionary WHODRUG 200204 | Assigned | |
QVAL | QNAM = "PDDREAS" (Reason for Discontinuation) | text | 21 | Reason for Discontinuation
| [CRF] Annotated Case Report Form 9 | |
QVAL | QNAM = "PDRESP" (Response) | text | 4 | PSRESPF
| [CRF] Annotated Case Report Form 9 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "RACE1" (Race 1) | text | 5 | Race [7 Terms] | [CRF] Annotated Case Report Form 6 | |
QVAL | QNAM = "RACE2" (Race 2) | text | 25 | Race [7 Terms] | [CRF] Annotated Case Report Form 6 | |
QVAL | QNAM = "RACE3" (Race 3) | text | 5 | Race [7 Terms] | [CRF] Annotated Case Report Form 6 | |
QVAL | QNAM = "RACEOTH" (Race, Other) | text | 14 | [CRF] Annotated Case Report Form 6 | ||
QVAL | QNAM = "RAND" (Randomized Population Flag) | text | 1 | No Yes Response Subset
| [CRF] Annotated Case Report Form 16 | |
QVAL | QNAM = "RANDNO" (Randomization Number) | text | 4 | [CRF] Annotated Case Report Form 16 | ||
QVAL | QNAM = "SAFETY" (Safety Population Flag) | text | 1 | No Yes Response Subset
| Derived | SAFETY = "Y" for randomized subjects who took at least one dose study medication. Null otherwise. |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "EGCLSIG" (Clinically Significant) | text | 1 | No Yes Response Subset
| [CRF] Annotated Case Report Form 12 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "SMNO" (Number of Tablets Per Day) | integer | 2 | [CRF] Annotated Case Report Form 20 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "LBCLSIG" (Clinically Significant) | text | 1 | No Yes Response Subset
| Derived | Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan. |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "RTRINIT" (Rater Initials) | text | 3 | [CRF] Annotated Case Report Form 13 14 17 | QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "RTRINIT" (Rater Initials) | text | 3 | [CRF] Annotated Case Report Form 13 14 17 | QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "RTRINIT" (Rater Initials) | text | 3 | [CRF] Annotated Case Report Form 13 14 17 | QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
QVAL | QNAM = "VSCLSIG" (Clinically Significant) | text | 1 | No Yes Response Subset
| Derived | Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan. |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
TSVAL | TSPARMCD = "ADDON" (Added on to Existing Treatments) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "AGEMAX" (Planned Maximum Age of Subjects) | integer | 2 | Protocol | ||
TSVAL | TSPARMCD = "AGEMIN" (Planned Minimum Age of Subjects) | integer | 2 | Protocol | ||
TSVAL | TSPARMCD = "AGESPAN" (Age Span) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "AGEU" (Age Unit) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "DOSE" (Dose per Administration) | integer | 2 | Protocol | ||
TSVAL | TSPARMCD = "DOSFRQ" (Dosing Frequency) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "DOSU" (Dose Units) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "LENGTH" (Trial Length) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "OBJPRIM" (Trial Primary Objective) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "OBJSEC" (Trial Secondary Objective) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "PLANSUB" (Planned Number of Subjects) | integer | 2 | Protocol | ||
TSVAL | TSPARMCD = "RANDOM" (Trial is Randomized) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "ROUTE" (Route of Administration) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "SEXPOP" (Sex of Participants) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "SPONSOR" (Clinical Study Sponsor) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "TBLIND" (Trial Blinding Schema) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "TCNTRL" (Control Type) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "TINDTP" (Trial Indication Type) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "TITLE" (Trial Title) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "TPHASE" (Trial Phase Classification) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "TRT" (Investigational Therapy or Treatment) | text | 57 | Protocol | ||
TSVAL | TSPARMCD = "TTYPE" (Trial Type) | text | 57 | Protocol |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
VSORRES | VSTESTCD = "DIABP" (Diastolic Blood Pressure) | integer | 2 | [CRF] Annotated Case Report Form 11 | ||
VSORRES | VSTESTCD = "FRMSIZE" (Body Frame Size) | text | 6 | Size
| [CRF] Annotated Case Report Form 11 | |
VSORRES | VSTESTCD = "HEIGHT" (Height) | float | 5.1 | [CRF] Annotated Case Report Form 11 | ||
VSORRES | VSTESTCD = "PULSE" (Pulse Rate) | integer | 2 | [CRF] Annotated Case Report Form 11 | ||
VSORRES | VSTESTCD = "SYSBP" (Systolic Blood Pressure) | integer | 3 | [CRF] Annotated Case Report Form 11 | ||
VSORRES | VSTESTCD = "WEIGHT" (Weight) | float | 5.1 | [CRF] Annotated Case Report Form 11 |
Variable | Where | Type | Length or Display Format | Controlled Terms or Format | Origin | Derivation / Comment |
---|---|---|---|---|---|---|
VSORRESU | VSTESTCD = "HEIGHT" (Height) | text | 5 | Unit (UH)
| [CRF] Annotated Case Report Form 11 | |
VSORRESU | VSTESTCD = "WEIGHT" (Weight) | text | 4 | Unit (UW)
| [CRF] Annotated Case Report Form 11 |
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Controlled Terms
Permitted Value (Code) |
---|
DOSE NOT CHANGED [C49504] |
DOSE REDUCED [C49505] |
DRUG INTERRUPTED [C49501] |
DRUG WITHDRAWN [C49502] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
AE [C49562] | Adverse Events |
Permitted Value (Code) |
---|
AFTER [C38008] |
Permitted Value (Code) |
---|
NOT RELATED |
POSSIBLY RELATED |
RELATED |
Permitted Value (Code) | Display Value (Decode) |
---|---|
MILD [C41338] | Grade 1 |
MODERATE [C41339] | Grade 2 |
SEVERE [C41340] | Grade 3 |
Permitted Value (Code) |
---|
Miracle Drug 10 mg |
Miracle Drug 20 mg |
Placebo |
Screen Failure |
Permitted Value (Code) | Display Value (Decode) |
---|---|
WONDER10 | Miracle Drug 10 mg |
WONDER20 | Miracle Drug 20 mg |
PLACEBO | Placebo |
SCRNFAIL | Screen Failure |
Permitted Value (Code) | Display Value (Decode) |
---|---|
1 | Very much improved |
2 | Much Improved |
3 | Minimally Improved |
4 | No change |
5 | Minimally worse |
6 | Much worse |
7 | Very much worse |
Permitted Value (Code) |
---|
CONCOMITANT MEDICATIONS |
PSYCHOTROPHIC DRUG TREATMENT HISTORY |
Permitted Value (Code) | Display Value (Decode) |
---|---|
CM [C49568] | Concomitant Meds |
Permitted Value (Code) |
---|
AFTER [C38008] |
Permitted Value (Code) |
---|
CAPSULE [C48480] |
IU [C48579] |
TABLET [C48542] |
VIAL [C48551] |
g [C48155] |
mL [C28254] |
mL/hr [*] |
mL/kg [C67411] |
mg [C28253] |
mg/kg [C67401] |
ug [C48152] |
ug/kg [C67396] |
Other [*] |
* Extended Value
Permitted Value (Code) | Display Value (Decode) |
---|---|
0 | Absent |
1 | Mild or Intermittent |
2 | Severe |
Permitted Value (Code) | Display Value (Decode) |
---|---|
DA [C49578] | Drug Accountability |
Permitted Value (Code) |
---|
Dispensed Amount [C78721] |
Returned Amount [C78722] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
DISPAMT [C78721] | Dispensed Amount |
RETAMT [C78722] | Returned Amount |
Permitted Value (Code) |
---|
ONGOING |
ADVERSE EVENT |
INSUFFICIENT RESPONSE |
SATISFACTORY RESPONSE |
OTHER |
Permitted Value (Code) | Display Value (Decode) |
---|---|
DM [C49572] | Demographics |
Permitted Value (Code) | Display Value (Decode) |
---|---|
DISPOSITION EVENT [C74590] | Disposition Event |
PROTOCOL MILESTONE [C74588] | Protocol Milestone |
Permitted Value (Code) | Display Value (Decode) |
---|---|
DS [C49576] | Disposition |
Permitted Value (Code) | Display Value (Decode) |
---|---|
EG [C49626] | Electrocardiogram |
Permitted Value (Code) | Display Value (Decode) |
---|---|
BEATS/MIN [C49673] | Beats per Minute |
msec [C41140] | Millisecond |
Permitted Value (Code) |
---|
Interpretation [C41255] |
QTcB - Bazett's Correction Formula [*] |
QTcF - Fridericia's Correction Formula [*] |
Summary (Mean) PR Duration [*] |
Summary (Mean) QRS Duration [*] |
Summary (Mean) QT Duration [*] |
Summary (Mean) Ventricular Rate [*] |
* Extended Value
Permitted Value (Code) | Display Value (Decode) |
---|---|
INTP [C41255] | Interpretation |
PRMEAN [*] | Summary (Mean) PR Duration |
QRSDUR [*] | Summary (Mean) QRS Duration |
QTCB [*] | QTcB - Bazett's Correction Formula |
QTCF [*] | QTcF - Fridericia's Correction Formula |
QTMEAN [*] | Summary (Mean) QT Duration |
VRMEAN [*] | Summary (Mean) Ventricular Rate |
* Extended Value
Permitted Value (Code) |
---|
SCREEN [*] |
TREATMENT [C101526] |
* Extended Value
Permitted Value (Code) |
---|
HISPANIC OR LATINO [C17459] |
NOT HISPANIC OR LATINO [C41222] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
EX [C49587] | Exposure |
Permitted Value (Code) |
---|
Miracle Drug |
Placebo |
Permitted Value (Code) | Display Value (Decode) |
---|---|
BID [C64496] | BD |
ONCE [C64576] | Once |
OTHER [C17649] | Other |
PRN [C64499] | As needed |
Q24H [C64515] | Every 24 hours |
QID [C64530] | 4 times per day |
QOD [C64525] | Every other day |
QS [*] | Every week |
TID [C64527] | 3 times per day |
* Extended Value
Permitted Value (Code) | Display Value (Decode) |
---|---|
TABLET [C42998] | tab |
Permitted Value (Code) | Display Value (Decode) |
---|---|
IE [C61536] | Inclusion/Exclusion |
Permitted Value (Code) |
---|
Did not respond to a standard course of medication Abc |
Has Xyz disease of at least 10 weeks duration confirmed by biopsy |
Is age 18 - 85 |
Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years |
Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment |
Is unable or unwilling to undergo multiple venipunctures |
Permitted Value (Code) | Display Value (Decode) |
---|---|
EXCL01 | Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment |
EXCL02 | Is unable or unwilling to undergo multiple venipunctures |
EXCL03 | Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years |
INCL01 | Is age 18 - 85 |
INCL02 | Has Xyz disease of at least 10 weeks duration confirmed by biopsy |
INCL03 | Did not respond to a standard course of medication Abc |
Permitted Value (Code) | Display Value (Decode) |
---|---|
LB [C49592] | Laboratory Data |
Permitted Value (Code) |
---|
% [C25613] |
X10^9/L [*] |
g/dL [C64783] |
mg/dL [C67015] |
ng/dL [C67326] |
pg/mL [*] |
* Extended Value
Permitted Value (Code) |
---|
Bilirubin [C38037] |
Blood Urea Nitrogen [C61019] |
Glucose [C105585] |
Hematocrit [C64796] |
Hemoglobin [C64848] |
Lymphocytes [C51949] |
Occult Blood [C74686] |
Vitamin B12 [C64817] |
Vitamin B9 [C74676] |
pH [C45997] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
BILI [C38037] | Bilirubin |
BUN [C61019] | Blood Urea Nitrogen |
GLUC [C105585] | Glucose |
HCT [C64796] | Hematocrit |
HGB [C64848] | Hemoglobin |
LYM [C51949] | Lymphocytes |
OCCBLD [C74686] | Occult Blood |
PH [C45997] | pH |
VITB12 [C64817] | Vitamin B12 |
VITB9 [C74676] | Vitamin B9 |
Permitted Value (Code) |
---|
DIVORCED [C51776] |
DOMESTIC PARTNER [C53262] |
LEGALLY SEPARATED [C51777] |
MARRIED [C51773] |
NEVER MARRIED [C51774] |
WIDOWED [C51775] |
Permitted Value (Code) |
---|
DIPSTICK [*] |
QUANT [*] |
* Extended Value
Permitted Value (Code) |
---|
Endocrine-Metabolic |
Eyes-Ears-Nose-Throat |
Genitourinary |
Musculoskeletal |
Neurological |
Permitted Value (Code) |
---|
MEDICAL AND SURGICAL HISTORY |
PSYCHIATRIC HISTORY |
Permitted Value (Code) | Display Value (Decode) |
---|---|
MH [C49603] | Medical History |
Permitted Value (Code) |
---|
BEFORE [C25629] |
DURING/AFTER [C49640] |
Permitted Value (Code) |
---|
ABNORMAL |
NORMAL |
Permitted Value (Code) |
---|
ADVERSE EVENT [C41331] |
COMPLETED [C25250] |
INFORMED CONSENT [*] |
LACK OF EFFICACY [C48226] |
LOST TO FOLLOW-UP [C48227] |
PHYSICIAN DECISION [C48250] |
PROTOCOL DEVIATION [C48251] |
RANDOMIZED [*] |
SCREEN FAILURE [C49628] |
WITHDRAWAL BY SUBJECT [C49634] |
* Extended Value
Permitted Value (Code) |
---|
ABNORMAL [C78802] |
HIGH [C78800] |
LOW [C78801] |
NORMAL [C78727] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
N [C49487] | No |
U [C17998] | Unknown |
Y [C49488] | Yes |
Permitted Value (Code) | Display Value (Decode) |
---|---|
N [C49487] | No |
NA [C48660] | Not Applicable |
Y [C49488] | Yes |
Permitted Value (Code) | Display Value (Decode) |
---|---|
PE [C49608] | Physical Exam |
Permitted Value (Code) |
---|
Abdomen |
Appearance/Skin |
Cardiovascular |
Eyes-Ears-Nose-Throat |
Head/Neck (Including Thyroid) |
Musculoskeletal |
Neurological |
Pulmonary |
Other |
Permitted Value (Code) | Display Value (Decode) |
---|---|
PE01 | Appearance/Skin |
PE02 | Head/Neck (Including Thyroid) |
PE03 | Eyes-Ears-Nose-Throat |
PE04 | Cardiovascular |
PE05 | Pulmonary |
PE06 | Abdomen |
PE07 | Neurological |
PE08 | Musculoskeletal |
PE09 | Other |
Permitted Value (Code) |
---|
GOOD |
NO CHANGE |
POOR |
Permitted Value (Code) | Display Value (Decode) |
---|---|
QS [C49609] | Questionnaires |
Permitted Value (Code) |
---|
Agitation |
Anxiety |
Appetite Loss |
Attention and Calculation |
Difficulty Falling Asleep |
Diurnal Variation of Mood |
Early Morning Awakening |
Global Improvement |
Irritability |
Lack of Energy |
Lack of Reactivity to Pleasant Events |
Language |
Loss of Interest |
Mood-Congruent Delusions |
Multiple Awakenings During Sleep |
Multiple Physical Complaints |
Orientation place score |
Orientation time score |
Pessimism |
Poor Self-Esteem |
Recall |
Registration |
Retardation |
Sadness |
Suicide |
Total Score |
Weight Loss |
Permitted Value (Code) | Display Value (Decode) |
---|---|
CGIGLOB | Global Improvement |
CSDD01 | Anxiety |
CSDD02 | Sadness |
CSDD03 | Lack of Reactivity to Pleasant Events |
CSDD04 | Irritability |
CSDD05 | Agitation |
CSDD06 | Retardation |
CSDD07 | Multiple Physical Complaints |
CSDD08 | Loss of Interest |
CSDD09 | Appetite Loss |
CSDD10 | Weight Loss |
CSDD11 | Lack of Energy |
CSDD12 | Diurnal Variation of Mood |
CSDD13 | Difficulty Falling Asleep |
CSDD14 | Multiple Awakenings During Sleep |
CSDD15 | Early Morning Awakening |
CSDD16 | Suicide |
CSDD17 | Poor Self-Esteem |
CSDD18 | Pessimism |
CSDD19 | Mood-Congruent Delusions |
CSDDTOT | Total Score |
MMSEA1 | Orientation time score |
MMSEA2 | Orientation place score |
MMSEB | Registration |
MMSEC | Attention and Calculation |
MMSED | Recall |
MMSEET | Language |
MMSETOT | Total Score |
Permitted Value (Code) |
---|
WHITE [C41261] |
AMERICAN INDIAN OR ALASKA NATIVE [C41259] |
BLACK OR AFRICAN AMERICAN [C16352] |
ASIAN [C41260] |
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219] |
OTHER [*] |
MULTIPLE [*] |
* Extended Value
Permitted Value (Code) |
---|
ORAL [C38288] |
SUBCUTANEOUS [C38299] |
INTRAMUSCULAR [C28161] |
INTRAVENOUS [C38276] |
RECTAL [C38295] |
TOPICAL [C38304] |
NASAL [C38284] |
INTRASINAL [C38262] |
OTHER [*] |
* Extended Value
Permitted Value (Code) | Display Value (Decode) |
---|---|
SC [C49610] | Subject Characteristics |
Permitted Value (Code) |
---|
Education Level [*] |
Marital Status [C25188] |
Subject Initials [*] |
* Extended Value
Permitted Value (Code) | Display Value (Decode) |
---|---|
EDLEVEL [*] | Education Level |
MARISTAT [C25188] | Marital Status |
SUBJINIT [*] | Subject Initials |
* Extended Value
Permitted Value (Code) | Display Value (Decode) |
---|---|
SE [C49616] | Subject Element |
Permitted Value (Code) | Display Value (Decode) |
---|---|
F [C16576] | Female |
M [C20197] | Male |
U [C17998] | Unknown |
Permitted Value (Code) |
---|
SMALL [C25376] |
MEDIUM [C49507] |
LARGE [C49508] |
Permitted Value (Code) |
---|
BLOOD [C12434] |
SERUM [C13325] |
URINE [C13283] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
SV [C49617] | Subject Visits |
Permitted Value (Code) | Display Value (Decode) |
---|---|
TA [C49618] | Trial Arms |
Permitted Value (Code) | Display Value (Decode) |
---|---|
TE [C49619] | Trial Elements |
Permitted Value (Code) | Display Value (Decode) |
---|---|
TI [C49620] | Trial Inclusion/Exclusion Criteria |
Permitted Value (Code) |
---|
COMPLETED |
DID NOT MEET INCLUSION CRITERIA #3 |
DISCONTINUED DUE TO ADVERSE EVENT |
DISCONTINUED DUE TO CONSENT WITHDRAWEL |
DISCONTINUED DUE TO LACK OF THERAPEUTIC RESPONSE |
DISCONTINUED DUE TO LOST TO FOLLOW UP |
DISCONTINUED DUE TO SPONSOR/INVESTIGATOR DECISION |
INFORMED CONSENT OBTAINED |
PATIENT DID NOT MEET INCLUSION/EXCLUSION CRITERIA AT SCREENING |
PROTOCOL VIOLATION |
RANDOMIZED |
Permitted Value (Code) | Display Value (Decode) |
---|---|
TS [C53483] | Trial Summary |
Permitted Value (Code) |
---|
Added on to Existing Treatments [C49703] |
Age Span [*] |
Age Unit [*] |
Clinical Study Sponsor [C70793] |
Control Type [C49647] |
Dose Units [C73558] |
Dose per Administration [C25488] |
Dosing Frequency [C89081] |
Investigational Therapy or Treatment [C41161] |
Planned Maximum Age of Subjects [C49694] |
Planned Minimum Age of Subjects [C49693] |
Planned Number of Subjects [C49692] |
Route of Administration [C38114] |
Sex of Participants [C49696] |
Trial Blinding Schema [C49658] |
Trial Indication Type [C49652] |
Trial Length [C49697] |
Trial Phase Classification [C48281] |
Trial Primary Objective [C85826] |
Trial Secondary Objective [C85827] |
Trial Title [C49802] |
Trial Type [C49660] |
Trial is Randomized [C25196] |
* Extended Value
Permitted Value (Code) | Display Value (Decode) |
---|---|
ADDON [C49703] | Added on to Existing Treatments |
AGEMAX [C49694] | Planned Maximum Age of Subjects |
AGEMIN [C49693] | Planned Minimum Age of Subjects |
AGESPAN [*] | Age Span |
AGEU [*] | Age Unit |
DOSE [C25488] | Dose per Administration |
DOSFRQ [C89081] | Dosing Frequency |
DOSU [C73558] | Dose Units |
LENGTH [C49697] | Trial Length |
OBJPRIM [C85826] | Trial Primary Objective |
OBJSEC [C85827] | Trial Secondary Objective |
PLANSUB [C49692] | Planned Number of Subjects |
RANDOM [C25196] | Trial is Randomized |
ROUTE [C38114] | Route of Administration |
SEXPOP [C49696] | Sex of Participants |
SPONSOR [C70793] | Clinical Study Sponsor |
TBLIND [C49658] | Trial Blinding Schema |
TCNTRL [C49647] | Control Type |
TINDTP [C49652] | Trial Indication Type |
TITLE [C49802] | Trial Title |
TPHASE [C48281] | Trial Phase Classification |
TRT [C41161] | Investigational Therapy or Treatment |
TTYPE [C49660] | Trial Type |
* Extended Value
Permitted Value (Code) | Display Value (Decode) |
---|---|
TV [C49621] | Trial Visits |
Permitted Value (Code) | Display Value (Decode) |
---|---|
IN [C48500] | Inch |
cm [C49668] | Centimeter |
Permitted Value (Code) | Display Value (Decode) |
---|---|
LB [C48531] | Pound |
kg [C28252] | Kilogram |
Permitted Value (Code) | Display Value (Decode) |
---|---|
VS [C49622] | Vital Signs |
Permitted Value (Code) | Display Value (Decode) |
---|---|
BEATS/MIN [C49673] | Beats per Minute |
cm [C49668] | Centimeter |
kg [C28252] | Kilogram |
mmHg [C49670] | Millimeter of Mercury |
Permitted Value (Code) |
---|
Body Frame Size [C49680] |
Diastolic Blood Pressure [C25299] |
Height [C25347] |
Pulse Rate [C49676] |
Systolic Blood Pressure [C25298] |
Weight [C25208] |
Permitted Value (Code) | Display Value (Decode) |
---|---|
DIABP [C25299] | Diastolic Blood Pressure |
FRMSIZE [C49680] | Body Frame Size |
HEIGHT [C25347] | Height |
PULSE [C49676] | Pulse Rate |
SYSBP [C25298] | Systolic Blood Pressure |
WEIGHT [C25208] | Weight |
Go to the top of the Define-XML document
External Dictionaries
Reference Name | External Dictionary | Dictionary Version |
---|---|---|
ISO3166 (CL.IS3166F) | ISO3166 | |
Adverse Event Dictionary (CL.AEDICT) | MEDDRA | 8.0 |
Drug Dictionary (CL.DRUGDCT) | WHODRUG | 200204 |
Go to the top of the Define-XML document
Computational Algorithms
Method | Type | Description |
---|---|---|
MT.AE.AEENDY | Computation | AEENDY = AEENDTC -RFSTDTC+1 if AEENDTC is on or after RFSTDTC. AEENDTC - RFSTDTC if AEENDTC precedes RFSTDTC |
MT.AE.AESEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.AE.AESTDY | Computation | AESTDY = AESTDTC - RFSTDTC+1 if AESTDTC is on or after RFSTDTC. AESTDTC - RFSTDTC if AESTDTC precedes RFSTDTC |
MT.AE.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.CM.CMENDY | Computation | CMENDY = CMENDTC - RFSTDTC +1 if CMENDTC is on or after RFSTDTC. CMENDTC - RFSTDTC if CMENDTC precedes RFSTDTC |
MT.CM.CMSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.CM.CMSTDY | Computation | CMSTDY = CMSTDTC - RFSTDTC +1 if CMSTDTC is on or after RFSTDTC. CMSTDTC - RFSTDTC if CMSTDTC precedes RFSTDTC |
MT.CM.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.DA.DADY | Computation | DADY = DADTC - RFSTDTC+1 if DADTC is on or after RFSTDTC. DADTC - RFSTDTC if DADTC precedes RFSTDTC. |
MT.DA.DASEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.DA.DASTRESC | Computation | DASTRESC = DAORRES |
MT.DA.DASTRESN | Computation | DASTRESN = numeric value of DAORRES, when DAORRES contains numeric data. |
MT.DA.DASTRESU | Computation | DASTRESU = DAORRESU |
MT.DA.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.DA.VISITNUM | Computation | Derived from DADTC and SVSTDTC. |
MT.DM.AGE | Computation | Age at Screening Date (Screening Date - Birth date). For the complete algorithm see the referenced external document. |
MT.DM.RFENDTC | Computation | RFENDTC = termination date, for safety subjects. Null for screen failures. |
MT.DM.RFSTDTC | Computation | RFSTDTC = first date/time of study drug, for safety subject. Null for screen failures. |
MT.DM.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.DS.DSSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.DS.DSSTDY | Computation | DSSTDY = DSSTDTC - RFSTDTC+1 if DSSTDTC is on or after RFSTDTC. DSSTDTC - RFSTDTC if DSSTDTC precedes RFSTDTC. Null if RFSTDTC is Null. |
MT.DS.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.EG.EGBLFL | Computation | Safety subjects only: EGBLFL = "Y" for last record with non Null EGORRES on or before the first dose date (RFSTDTC). Null otherwise |
MT.EG.EGDRVFL | Computation | EGDRVFL = "Y" for derived EGTESTCDs QTCB and QTCF. Null otherwise. |
MT.EG.EGDY | Computation | EGDY = EGDTC-RFSTDTC+1 if EGDTC is on or after RFTSDTC. EGDTC - RFSTDTC if EGDTC precedes RFSTDTC. |
MT.EG.EGSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.EG.EGSTRESC | Computation | Data collected in non-standard units is converted using standard conversion factors to standard units. |
MT.EG.EGSTRESN | Computation | EGSTRESN = numeric value of EGSTRESC, when EGSTRESC contains numeric data. |
MT.EG.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.EX.EXDOSE | Computation | If ARMCD=WONDER10 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 10. If ARMCD=WONDER20 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 20. If ARMCD=PLACEBO then EXDOSE = 0. |
MT.EX.EXDOSU | Computation | Derived from ARM, ARMCD - equal to mg |
MT.EX.EXENDY | Computation | EXENDY = EXENDTC-RFSTDTC+1 if EXENDTC is on or after RFSTDTC. EXENDTC - RFSTDTC if EXENDTC precedes RFSTDTC. |
MT.EX.EXSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.EX.EXSTDY | Computation | EXSTDY = EXSTDTC - RFSTDTC+1 if EXSTDTC is on or after RFSTDTC. EXSTDTC - RFSTDTC if EXSTDTC precedes RFSTDTC. |
MT.EX.EXTRT | Computation | Derived from ARM, ARMCD |
MT.EX.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.IE.IESEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.IE.IESTRESC | Computation | IESTRESC = IEORRES |
MT.IE.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.LB.LBBLFL | Computation | Safety subjects only: LBBLFL = "Y" for last record with non Null LBORRES on or before the first dose date (RFSTDTC). Null otherwise. |
MT.LB.LBDY | Computation | LBDY = LBDTC-RFSTDTC+1 if LBDTC is on or after RFSTDTC. LBDTC - RFSTDTC if LBDTC precedes RFSTDTC. |
MT.LB.LBNRIND | Computation | Reference Range Indicator based upon standard results and ranges. |
MT.LB.LBSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.LB.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.MH.MHSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.MH.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.PE.PEDY | Computation | PEDY = PEDTC-RFSTDTC+1 if PEDTC is on or after RFSTDTC. PEDTC - RFSTDTC if PEDTC precedes RFSTDTC. |
MT.PE.PESEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.PE.PESTRESC | Computation | PESTRESC = PEORRES |
MT.PE.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.QSCG.QSDY | Computation | QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC. |
MT.QSCG.QSSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.QSCG.QSSTRESC | Computation | If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data. |
MT.QSCG.QSSTRESN | Computation | When QSORRES is numeric then QSSTRESN equal to numeric result |
MT.QSCG.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.QSCS.QSBLFL | Computation | Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise. |
MT.QSCS.QSDY | Computation | QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC. |
MT.QSCS.QSSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.QSCS.QSSTRESC | Computation | If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data. |
MT.QSCS.QSSTRESN | Computation | When QSORRES is numeric then QSSTRESN equal to numeric result |
MT.QSCS.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.QSMM.QSBLFL | Computation | Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise. |
MT.QSMM.QSDY | Computation | QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC. |
MT.QSMM.QSSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.QSMM.QSSTRESC | Computation | If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data. |
MT.QSMM.QSSTRESN | Computation | When QSORRES is numeric then QSSTRESN equal to numeric result |
MT.QSMM.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.RELREC.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.RELREC.RELID | Computation | All records for the same USUBJID with the same RELID are considered related. |
MT.RELREC.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SC.SCDY | Computation | SCDY = SCDTC-RFSTDTC+1 if SCDTC is on or after RFSTDTC. SCDTC - RFSTDTC if SCDTC precedes RFSTDTC. |
MT.SC.SCSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.SC.SCSTRESC | Computation | SCSTRESC = SCORRES |
MT.SC.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SE.SEENDTC | Computation | If Element = SCREEN, derived from SVENDTC where VISIT = SCREENING. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT or from the latest EXENDTC from EX whichever is later. For treatment Elements, derived from last EXENDTC for the element. For the complete algorithm see the referenced external document. |
MT.SE.SESEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.SE.SESTDTC | Computation | If Element = SCREEN, derived from SVSTDTC where VISIT = SCREENING or from DS where DSDECOD = 'INFORMED CONSENT', whichever is earliest. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT. For treatment Elements, derived from first EXSTDTC for the element. For the complete algorithm see the referenced external document. |
MT.SE.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPAE.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPAE.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPCM.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPCM.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPDM.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPDM.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPEG.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPEG.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPEX.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPEX.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPLB.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPLB.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPQSCG.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPQSCG.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPQSCS.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPQSCS.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPQSMM.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPQSMM.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SUPPVS.RDOMAIN | Computation | Domain abbreviation from where data originated. |
MT.SUPPVS.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SV.SVENDTC | Computation | SVENDTC = SVSTDTC |
MT.SV.SVSTDTC | Computation | Derived from visit-based subject-level domains |
MT.SV.SVSTDY | Computation | SVSTDY = SVSTDTC-RFSTDTC+1 if SVSTDTC is on or after RFSTDTC. SVSTDTC - RFSTDTC if SVSTDTC precedes RFSTDTC. |
MT.SV.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.SV.VISIT | Computation | Derived from visit-based subject-level domains |
MT.SV.VISITNUM | Computation | Derived from visit-based subject-level domains |
MT.TS.TSSEQ | Computation | Sequential number identifying records within each TSPARM in the domain. |
MT.VS.USUBJID | Computation | Concatenation of STUDYID and SUBJID |
MT.VS.VSBLFL | Computation | Safety subjects only: VSBLFL = "Y" for last record with non Null VSORRES on or before the first dose date (RFSTDTC). Null otherwise. |
MT.VS.VSDY | Computation | VSDY = VSDTC-RFSTDTC+1 if VSDTC is on or after RFSTDTC. VSDTC - RFSTDTC if VSDTC precedes RFSTDTC. |
MT.VS.VSSEQ | Computation | Sequential number identifying records within each USUBJID in the domain. |
MT.VS.VSSTRESC | Computation | Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm). |
MT.VS.VSSTRESN | Computation | VSSTRESN = numeric value of VSSTRESC, when VSSTRESC contains numeric data. |
MT.EG.EGSTRESC.WC.EG.EGSTRESC.00008 | Computation | QTcB = QT interval / square root of (60 / heart rate). For the complete algorithm see the referenced external document. |
MT.EG.EGSTRESC.WC.EG.EGSTRESC.00009 | Computation | QTcF = QT interval / cubic root of (60 / heart rate). For the complete algorithm see the referenced external document. |
MT.SUPPAE.QVAL.WC.SUPPAE.QVAL.00068 | Computation | AETRTEM = "Y" if Adverse Event was not present prior to the RFSTDTC, or it was present prior to the RFSTDTC but increased in severity during the treatment period. Null otherwise. |
MT.SUPPDM.QVAL.WC.SUPPDM.QVAL.00083 | Computation | SAFETY = "Y" for randomized subjects who took at least one dose study medication. Null otherwise. |
MT.SUPPLB.QVAL.WC.SUPPLB.QVAL.00086 | Computation | Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan. |
MT.SUPPVS.QVAL.WC.SUPPVS.QVAL.00090 | Computation | Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan. |
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Comments
CommentOID | Description |
---|---|
COM.DM | See Reviewer's Guide, Section 2.1 Demographics |
COM.QSCG | QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. |
COM.QSCS | QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. |
COM.QSMM | QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. |
COM.CM.CMCLAS | Coded to ATC level 3 Term based on CMINDC |
COM.CM.CMCLASCD | Coded to ATC level 3 Code based on CMINDC |
COM.CM.CMROUTE | Free text from CRF mapped to CDISC CT |
COM.DM.AGEU | Defaulted to YEARS |
COM.DM.ARM | Assigned from TA.ARM based on ARMCD. |
COM.DM.ARMCD | Assigned based on Randomization Number. See Note 2.1 |
COM.DS.DSDECOD | CRF controlled terminology was mapped to match CDISC controlled terminology. |
COM.EG.EGEVAL | Equal to INVESTIGATOR for CRF data |
COM.EG.EGPOS | Equal to SUPINE |
COM.EG.EGSPID | ECG parameter ordering variable |
COM.EG.VISITNUM | Assigned from the TV domain based on the VISIT |
COM.IE.VISITNUM | Assigned from the TV domain based on the VISIT |
COM.LB.LBREFID | Accession number |
COM.MH.MHBODSYS | Assigned for Medical History but not Psychiatric History |
COM.MH.MHENRF | CRF controlled terminology was mapped to match CDISC controlled terminology. |
COM.PE.VISITNUM | Assigned from the TV domain based on the VISIT |
COM.QSCG.VISITNUM | Assigned from the TV domain based on the VISIT |
COM.QSCS.VISITNUM | Assigned from the TV domain based on the VISIT |
COM.QSMM.VISITNUM | Assigned from the TV domain based on the VISIT |
COM.RELREC.IDVAR | Name of the variables for the related records. |
COM.RELREC.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.RELREC.RELTYPE | All values are null since this is used only when identifying a dataset-level relationship. |
COM.SUPPAE.IDVAR | Name of the variables for the related records. |
COM.SUPPAE.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.SUPPCM.IDVAR | Name of the variables for the related records. |
COM.SUPPCM.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.SUPPDM.IDVAR | Name of the variables for the related records. |
COM.SUPPDM.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.SUPPEG.IDVAR | Name of the variables for the related records. |
COM.SUPPEG.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.SUPPEX.IDVAR | Name of the variables for the related records. |
COM.SUPPEX.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.SUPPLB.IDVAR | Name of the variables for the related records. |
COM.SUPPLB.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.SUPPQSCG.IDVAR | Name of the variables for the related records. |
COM.SUPPQSCG.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.SUPPQSCS.IDVAR | Name of the variables for the related records. |
COM.SUPPQSCS.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.SUPPQSMM.IDVAR | Name of the variables for the related records. |
COM.SUPPQSMM.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.SUPPVS.IDVAR | Name of the variables for the related records. |
COM.SUPPVS.IDVARVAL | Value of identifying variable described in IDVAR. |
COM.VS.VISITNUM | Assigned from the TV domain based on the VISIT |
COM.VS.VSSTRESU | Standard units consistent with CDISC controlled terminology |
COM.SUPPQSCG.QVAL.WC.SUPPQSCG.QVAL.00087 | QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17 |
COM.SUPPQSCS.QVAL.WC.SUPPQSCS.QVAL.00088 | QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17 |
COM.SUPPQSMM.QVAL.WC.SUPPQSMM.QVAL.00089 | QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17 |
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