ADaMIG OCCDS v1.1 scraping for specifications

Variable Name,Variable Label,Type,Variable Grouping,CDISC Notes,Seq. for Order,Class,Core,SubClass ADVERSE EVENT Core,Controlled Terms,Codelist,Controlled Termsa
STUDYID,Study Identifier,Char, Identifier ,XX.STUDYID,1,OCCDS,Req,Req,,,
USUBJID,Unique Subject Identifier,Char, Identifier ,XX.USUBJID,2,OCCDS,Req,Req,,,
SUBJID,Subject Identifier for the Study,Char, Identifier ,ADSL.SUBJID,3,OCCDS,Perm,Perm,,,
SITEID,Study Site Identifier,Char, Identifier ,ADSL.SITEID,4,OCCDS,Perm,Perm,,,
--SEQ,Sequence Number,Num,Row Identifier ,"XX.--SEQ \n Identifies the sequence number in SDTM domain XX that is the source for this row. This variable would be copied unchanged from the SDTM domain XX. Required for traceability back to SDTM when rows in the dataset are created from a single SDTM domain. This may be missing for derived rows. \n For SubClass ADVERSE EVENT, use AESEQ, copied from SDTM AE.AESEQ.",1,OCCDS,Cond,Req,,,
SRCDOM,Source Data,Char,Row Identifier ,"Identifies the name of the domain or dataset that is the source for this row. If the source data is a supplemental qualifier in SDTM, this variable will contain the value of RDOMAIN in SUPP-- or SUPPQUAL. Used when rows in the OCCDS dataset are from multiple SDTM domains or from one or more ADaM datasets. Not to be used in conjunction with --SEQ. This may be missing for derived rows. \n For SubClass ADVERSE EVENT, AESEQ is used rather than SRCDOM and SRCSEQ.",2,OCCDS,Perm,Not used,,,
SRCSEQ,Source Sequence Number,Num,Row Identifier ,"Identifies the sequence number that is the source for this row. If SRCDOM is a SUPPQUAL, then this variable will contain the sequence number of the relevant related domain record. Used when rows in the OCCDS dataset are from multiple SDTM domains or from one or more ADaM datasets. Not to be used in conjunction with --SEQ. This may be missing for derived rows. \n For SubClass ADVERSE EVENT, AESEQ is used rather than SRCDOM and SRCSEQ.",3,OCCDS,Perm,Not used,,,
ASEQ,Analysis Sequence Number,Num,Row Identifier ,"Sequence number given to ensure uniqueness of subject records within an ADaM dataset. \n ASEQ is useful for traceability when the OCCDS dataset is used as input to another ADaM dataset and the --SEQ variable is not included or unique. ASEQ is described in more detail in ADaMIG v1.2, Section 3.3.1, Identifier Variables for BDS Datasets.",4,OCCDS,Perm,Perm,,,
--TERM,Reported Term,Char,MedDRA Dictionary Coding ,"Copied from XX.--TERM \n This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2.2, The Events Observation Class, and SDTMIG v3.3 Section 6.2, Models for Events Domains, for details.",1,OCCDS,Req,Req,,,
--DECOD,Dictionary-Derived Term,Char,MedDRA Dictionary Coding ,Copied from XX.--DECOD \n This variable is typically one of the primary variables used in an analysis and would be brought in from the SDTM domain. Equivalent to the MedDRA PT. All other SDTM domain variables and supplemental qualifiers needed for analysis or traceability should also be included. Include the dictionary version in the metadata. \n Conditional on whether coded and used for analysis. Required for adverse event data.,2,OCCDS,Cond,Req,MedDRA,,
--BODSYS,Body System or Organ Class,Char,MedDRA Dictionary Coding ,Copied from XX.--BODSYS \n Include the dictionary version in the metadata. \n Conditional on whether coded and used for analysis. Required for adverse event data.,3,OCCDS,Cond,Req,MedDRA,,
--BDSYCD,Body System or Organ Class Code,Num,MedDRA Dictionary Coding ,Copied from XX.--BDSYCD or the supplemental qualifier \n This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata.,4,OCCDS,Perm,Req,MedDRA,,
--LLT,Lowest Level Term,Char,MedDRA Dictionary Coding ,Copied from XX.-- LLT or the supplemental qualifier \n Include the dictionary version in the metadata. \n Conditional on whether coded and used for analysis.,5,OCCDS,Cond,Req,MedDRA,,
--LLTCD,Lowest Level Term Code,Num,MedDRA Dictionary Coding ,Copied from XX.--LLTCD or the supplemental qualifier \n Include the dictionary version in the metadata.,6,OCCDS,Perm,Req,MedDRA,,
--PTCD,Preferred Term Code,Num,MedDRA Dictionary Coding ,Copied from XX.--PTCD or the supplemental qualifier \n Include the dictionary version in the metadata.,7,OCCDS,Perm,Req,MedDRA,,
--HLT,High Level Term,Char,MedDRA Dictionary Coding ,Copied from XX.--HLT or the supplemental qualifier \n Include the dictionary version in the metadata. \n Conditional on whether used for analysis.,8,OCCDS,Cond,Req,MedDRA,,
--HLTCD,High Level Term Code,Num,MedDRA Dictionary Coding ,Copied from XX.--HLTCD or the supplemental qualifier \n Include the dictionary version in the metadata.,9,OCCDS,Perm,Req,MedDRA,,
--HLGT,High Level Group Term,Char,MedDRA Dictionary Coding ,Copied from XX.--HLGT or the supplemental qualifier \n Include the dictionary version in the metadata. \n Conditional on whether used for analysis.,10,OCCDS,Cond,Req,MedDRA,,
-‑HLGTCD,High Level Group Term Code,Num,MedDRA Dictionary Coding ,Copied from XX.--HLGTCD or the supplemental qualifier \n Include the dictionary version in the metadata.,11,OCCDS,Perm,Req,MedDRA,,
--SOC,Primary System Organ Class,Char,MedDRA Dictionary Coding ,Copied from XX.--SOC or the supplemental qualifier \n Include the dictionary version in the metadata. \n Conditional on whether a secondary SOC was used for analysis.,12,OCCDS,Cond,Req,MedDRA,,
--SOCCD,Primary System Organ Class Code,Num,MedDRA Dictionary Coding ,Copied from XX.--SOCCD or the supplemental qualifier \n Include the dictionary version in the metadata.,13,OCCDS,Perm,Req,MedDRA,,
CMTRT,"Reported Name of Drug, Med, or Therapy",Char,WHO Drug Dictionary Coding ,CM.CMTRT,1,OCCDS,Req,Not Used,,,
CMDECOD,Standardized Medication Name,Char,WHO Drug Dictionary Coding ,CM.CMDECOD \n This is typically one of the primary variables used in CM analysis and would be copied from the SDTM CM domain. Include the dictionary version in the variable metadata. \n Conditional on whether coded and used for analysis.,2,OCCDS,Cond,Not Used,WHO Drug,,
CMCLAS,Medication Class,Char,WHO Drug Dictionary Coding ,CM.CMCLAS \n Include the dictionary version in the metadata.,3,OCCDS,Perm,Not Used,,,
CMCLASCD,Medication Class Code,Char,WHO Drug Dictionary Coding ,CM.CMCLASCD \n Include the dictionary version in the metadata.,4,OCCDS,Perm,Not Used,,,
ATCy,ATC Level y Text,Char,WHO Drug Dictionary Coding ,"Corresponds to the ATC Level Text for WHO Drug. Include the dictionary version in the variable metadata. \n Conditional, based on analysis at multiple levels (y)",5,OCCDS,Cond,Not Used,WHO Drug,,
ATCyCD,ATC Level y Code,Char,WHO Drug Dictionary Coding ,"Corresponds to the ATC Level Code for WHO Drug. Include the dictionary version in the variable metadata. \n Conditional, based on analysis at multiple levels (y)",6,OCCDS,Cond,Not Used,WHO Drug,,
--CAT,Category,Char,Other Categorization ,"Copied from XX.--CAT \n This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2, The General Observation Classes, and SDTMIG v3.3 Section 6, Domain Models Based on the General Observation Classes, for details.",1,OCCDS,Perm,Perm,,,
--SCAT,Subcategory,Char,Other Categorization ,"Copied from XX.--SCAT \n This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2, The General Observation Classes, and SDTMIG v3.3 Section 6, Domain Models Based on the General Observation Classes, for details.",2,OCCDS,Perm,Perm,,,
ACATy,Analysis Category y,Char,Other Categorization ,"Category used in analysis. May be derived from --CAT and/or --SCAT. Examples include records of special interest like prohibited medications, concomitant medications taken during an infusion reaction, growth factors, antimicrobial medications, and other such categories not defined elsewhere or present in SDTM domains.",3,OCCDS,Perm,Perm,,,
--STDTC,Start Date/Time of Observation,Char,Timing ,"Copied from XX.–STDTC \n Conditional on whether start date is pertinent for study and is populated in SDTM \n This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2.5, Timing Variables for All Classes, and SDTMIG v3.3 Section 6, Domain Models Based on the General Observation Classes for details.",1,OCCDS,Cond,Req,ISO 8601,,
ASTDT,Analysis Start Date,Num,Timing ,"Created from converting XX.--STDTC from character ISO 8601 format to numeric date format, applying imputation rules if specified in the statistical analysis plan (SAP) or metadata \n Conditional on whether start date is pertinent for study and is populated in SDTM",2,OCCDS,Cond,Req,,,
ASTTM,Analysis Start Time,Num,Timing ,"Created from converting XX.--STDTC from character ISO 8601 format to numeric time format, applying imputation rules if specified in the SAP or metadata \n Conditional on whether start time is pertinent for study and is populated in SDTM",3,OCCDS,Cond,Cond,,,
ASTDTM,Analysis Start Datetime,Num,Timing ,"Created from converting XX.--STDTC from character ISO 8601 format to numeric datetime format, applying imputation rules if specified in the SAP or metadata \n Conditional on whether start datetime is pertinent for study and is populated in SDTM",4,OCCDS,Cond,Cond,,,
ASTDTF,Analysis Start Date Imputation Flag,Char,Timing ,"The level of imputation of analysis start date. Imputation flags are described in ADaMIG v1.2 Section 3.1.3, Date and Time Imputation Flag Variables. \n Conditional on whether ASTDT (or the date part of ASTDTM) was imputed",5,OCCDS,Cond,Cond,,(DATEFL),
ASTTMF,Analysis Start Time Imputation Flag,Char,Timing ,"The level of imputation of analysis start time. Imputation flags are described in ADaMIG v1.2 Section 3.1.3, Date and Time Imputation Flag Variables. \n Conditional on whether ASTTM (or the time part of ASTDTM) was imputed",6,OCCDS,Cond,Cond,,(TIMEFL),
--ENDTC,End Date/Time of Observation,Char,Timing ,"Copied from XX.--ENDTC \n Conditional on whether end date is pertinent for study and is populated in SDTM \n This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2.5, Timing Variables for All Classes, and SDTMIG v3.3 Section 6, Domain Models Based on the General Observation Classes, for details.",7,OCCDS,Cond,Req,ISO 8601,,
AENDT,Analysis End Date,Num,Timing ,"Created from converting XX.--ENDTC from character ISO 8601 format to numeric date format, applying imputation rules if specified in the SAP or metadata \n Conditional on whether end date is pertinent for study and is populated in SDTM",8,OCCDS,Cond,Req,,,
AENTM,Analysis End Time,Num,Timing ,"Created from converting XX.--ENDTC from character ISO 8601 format to numeric time format, applying imputation rules if specified in the SAP or metadata \n Conditional on whether end time is pertinent for study and is populated in SDTM",9,OCCDS,Cond,Cond,,,
AENDTM,Analysis End Datetime,Num,Timing ,"Created from converting XX.--ENDTC from character ISO 8601 format to numeric datetime format, applying imputation rules if specified in the SAP or metadata \n Conditional on whether end datetime is pertinent for study and is populated in SDTM",10,OCCDS,Cond,Cond,,,
AENDTF,Analysis End Date Imputation Flag,Char,Timing ,"The level of imputation of analysis end date. Imputation flags are described in the ADaMIG v1.2 Section 3.1.3, Date and Time Imputation Flag Variables. \n Conditional on whether AENDT (or the date part of AENDTM) was imputed",11,OCCDS,Cond,Cond,,(DATEFL),
AENTMF,Analysis End Time Imputation Flag,Char,Timing ,"The level of imputation of analysis end time. Imputation flags are described in the ADaMIG v1.2 Section 3.1.3, Date and Time Imputation Flag Variables. \n Conditional on whether AENTM (or the date part of AENDTM) was imputed",12,OCCDS,Cond,Cond,,(TIMEFL),
ASTDY,Analysis Start Relative Day,Num,Timing ,"The number of days from an anchor date (not necessarily DM.RFSTDTC) to ASTDT \n Example derivation: \n ASTDT - ADSL.TRTSDT + 1 if ASTDT >= ADSL.TRTSDT, else ASTDT - ADSL.TRTSDT if ASTDT< ADSL.TRTSDT \n This variable may instead be copied from --STDY. \n Conditional on whether analysis start relative day is pertinent to the study",13,OCCDS,Cond,Req,,,
--STDY,Study Day of Start of Observation*,Num,Timing ,"Copied from XX.--STDY \n ASTDY may differ from --STDY due to date imputation and the option in ADaM to use a reference date other than SDTM's RFSTDTC. Including XX.--STDY in addition to ASTDY adds traceability. \n For SubClass ADVERSE EVENT, conditional on whether the AESTDY variable is in the SDTM AE dataset",14,OCCDS,Perm,Cond,,,
AENDY,Analysis End Relative Day,Num,Timing ,"The number of days from an anchor date (not necessarily DM.RFSTDTC) to AENDT \n Example derivation: \n AENDT - ADSL.TRTSDT + 1 if AENDT >= ADSL.TRTSDT, else AENDT - ADSL.TRTSDT if AENDT < ADSL.TRTSDT \n This variable may instead be copied from --ENDY.",15,OCCDS,Perm,Req,,,
--ENDY,Study Day of End of Observation*,Num,Timing ,"Copied from XX.--ENDY \n AENDY may differ from --ENDY due to date imputation and the option in ADaM to use a reference date other than SDTM's RFSTDTC. Including XX.--ENDY in addition to AENDY adds traceability. \n For SubClass ADVERSE EVENT, conditional on whether the AEENDY variable is in the SDTM AE dataset",16,OCCDS,Perm,Cond,,,
ADURN,Analysis Duration (N),Num,Timing ,Derive from ASTDT (or ASTDTM) and AENDT (or AENDTM).,17,OCCDS,Perm,Perm,,,
ADURU,Analysis Duration Units,Char,Timing ,Conditional on whether ADURN is included,18,OCCDS,Cond,Cond,,(UNIT),
--DUR,Duration of XX,Char,Timing ,"Copied from XX.--DUR \n Because --DUR is a collected field and ADURN is derived, the values will often differ. Including XX.--DUR in addition to ADURN adds traceability. \n For SubClass ADVERSE EVENT, conditional on whether the AEDUR variable is in the SDTM AE dataset",19,OCCDS,Perm,Cond,ISO 8601,,
APERIOD,Period,Num,Timing ,"APERIOD is a record-level timing variable that represents the analysis period within the study associated with the record for analysis purposes. The value of APERIOD (if populated) must be one of the xx values found in the ADSL TRTxxP variables. See ADaMIG v1.2 Section 3.3.3, Timing Variables for BDS variables for more information on this variable. \n For SubClass ADVERSE EVENT, conditional on whether multiple analysis periods are defined for the study",20,OCCDS,Perm,Cond,,,
APERIODC,Period (C),Char,Timing ,Text characterizing to which period the record belongs. One-to-one map to APERIOD.,21,OCCDS,Perm,Perm,,,
APHASE,Phase,Char,Timing ,"APHASE is a categorization of timing within a study, for example a higher-level categorization of APERIOD or an analysis epoch. For example, APHASE could describe spans of time for SCREENING, ON TREATMENT, and FOLLOW-UP. See the ADaM Implementation Guide v1.2 for more information on this variable.",22,OCCDS,Perm,Perm,,,
--OCCUR,XX Occurrence,Char,SDTM Indicator ,"Copied from XX.--OCCUR \n Conditional on whether this content is pertinent for analysis and is populated in SDTM \n SDTM does not allow variable AEOCCUR, so this variable is not available to include in ADaM.",1,OCCDS,Cond,Not used,,(NY),
--PRESP,XX Pre-Specified,Char,SDTM Indicator ,Copied from XX.--PRESP \n Conditional on whether this content is pertinent for analysis and is populated in SDTM,2,OCCDS,Cond,Cond,,(NY),
ANLzzFL,Analysis Flag zz,Char, Indicator ,"The ANLzzFL flag is useful in many circumstances; an example is when more than 1 coding path is included for analysis, in which case separate analysis flags could be used to denote primary coding path or the records used for analysis from each coding path. A codelist of Y, N, null may be used as described in ADaMIG v1.2 Section 3.3.8, Indicator Variables for BDS Datasets. \n This variable is conditional on whether analysis records flags are needed for analysis.",1,OCCDS,Cond,Cond,,Y,
TRTEMFL,Treatment Emergent Analysis Flag,Char,Adverse Events Indicator ,"Treatment-emergent flag as defined for analysis \n Example derivation: \n If ADSL.TRTSDT<=ASTDT<=ADSL.TRTEDT + x days then TRTEMFL=""Y"" \n The number x in this derivation is defined by the producer and often incorporates the known half-life of the drug. \n For datasets other than SubClass ADVERSE EVENT, this variable is conditional on whether the concept of treatment emergent is a key feature of the analysis.",1,OCCDS,Cond,Req,,Y,
TREMxxFL,Treatment Emergent Period xx Flag,Char,Adverse Events Indicator ,"This variable is required if there are multiple periods where treatment emergence is a key feature of the analysis for each period. \n If TREMxxFL is included, TRTEMFL is defined as the overall treatment-emergent flag.",2,OCCDS,Cond,Cond,,Y,
TRTEMwFL,Treatment Emergent Analysis w Flag,Char,Adverse Events Indicator ,"This variable is used if there are other analysis needs (e.g., different cut-offs) where treatment emergence is a key feature of the analysis. \n If TREMwFL is included, TRTEMFL is defined as the overall treatment-emergent flag.",3,OCCDS,Perm,Perm,,Y,
AETRTEM,Treatment Emergent Flag,Char,Adverse Events Indicator ,"Treatment-emergent flag from SDTM, if available. See SDTMIG v3.3, Appendix C2, Supplemental Qualifiers Name Codes, for more information. \n Derivation: \n SUPPAE.QVAL where QNAM=""AETRTEM"" \n TRTEMFL may differ from AETRTEM due to different definitions, date imputation, and other analysis rules. Including AETRTEM in addition to TRTEMFL will add traceability. \n For SubClass ADVERSE EVENT, conditional on whether the AETRTEM variable is in the SDTM AE dataset and populated",4,OCCDS,Perm,Cond,,(NY),
ONTRTFL,On Treatment Record Flag,Char,Concomitant Medications Indicator ,"Character indicator of whether the observation occurred while the subject was on treatment. A codelist of Y, N, null may be used as described in ADaMIG Section 3.3.8, Indicator Variables for BDS Datasets. \n Example derivation: \n If ADSL.TRTSDT <= ASTDT <= ADSL.TRTEDT then ONTRTFL = ""Y"" \n This variable is conditional on whether the concept of on treatment is a feature of the study and used in analysis.",1,OCCDS,Cond,Perm,,Y,
ONTRxxFL,On Treatment Period xx Flag,Char,Concomitant Medications Indicator ,"This variable is used if there are multiple periods where on treatment is a key feature of the analysis for each period. \n If ONTRxxFL is included, ONTRTFL is defined as the overall on-treatment flag.",2,OCCDS,Perm,Perm,,Y,
ONTRTwFL,On Treatment Record w Flag,Char,Concomitant Medications Indicator ,"This variable is used if there are other analysis needs (e.g., different cut-offs) where on treatment is a key feature of the analysis. \n If ONTRTwFL is included, ONTRTFL is defined as the overall on-treatment flag.",3,OCCDS,Perm,Perm,,Y,
PREFL,Pre-treatment Flag,Char,Adverse Events and Concomitant Medications Indicator ,Character indicator of whether the observation occurred before the subject started treatment \n Example derivation: \n If ASTDT < ADSL.TRTSDT then PREFL="Y" \n This variable is conditional on whether the concept of pre-treatment is a feature of the study and used in analysis.,1,OCCDS,Cond,Cond,,Y,
FUPFL,Follow-up Flag,Char,Adverse Events and Concomitant Medications Indicator ,Character indicator of whether the observation occurred while the subject was on follow-up \n Example derivation: \n If ASTDT > ADSL.TRTEDT then FUPFL="Y" \n This variable is conditional on whether the concept of follow-up is a feature of the study and used in analysis.,2,OCCDS,Cond,Cond,,Y,
AOCCFL,1st Occurrence within Subject Flag,Char, Occurrence Flag ,Character indicator for the first occurrence of any event/intervention/finding within the subject \n Example derivation: Sort the data in the required order and flag the first treatment emergent record for each subject.,1,OCCDS,Perm,Perm,,Y,
AOCCPFL,1st Occurrence of Preferred Term Flag,Char, Occurrence Flag ,Character indicator for the first occurrence of the preferred term within the subject \n Example derivation: Sort the data in the required order and flag the first treatment emergent record for each --DECOD for each subject.,2,OCCDS,Perm,Perm,,Y,
AOCCIFL,1st Max Sev./Int. Occurrence Flag,Char, Occurrence Flag ,Character indicator for the first occurrence of the event/intervention/finding with the maximum severity/intensity within the subject \n Example derivation: Sort the data in the required order and flag the first treatment emergent record for maximum severity for each subject.,3,OCCDS,Perm,Perm,,Y,
AOCCPIFL,1st Max Sev./Int. Occur Within PT Flag,Char, Occurrence Flag ,Character indicator for the first occurrence of the maximum severity/intensity within the subject and preferred term \n Example derivation: Sort the data in the required order and flag the first treatment emergent record for maximum severity within preferred term for each subject.,4,OCCDS,Perm,Perm,,Y,
AOCCzzFL,1st Occurrence of ...,Char, Occurrence Flag ,Additional flag variables as needed for analysis. Derivation rules for these flags need to be described in the metadata.,5,OCCDS,Perm,Perm,,Y,
AOCCSFL,1st Occurrence of SOC Flag,Char,MedDRA Occurrence Flag ,Character indicator for the first occurrence of the system organ class within the subject \n Example derivation: Sort the data in the required order and flag the first treatment-emergent record for each body system for each subject.,1,OCCDS,Perm,Perm,,Y,
AOCCSIFL,1st Max Sev./Int. Occur Within SOC Flag,Char,MedDRA Occurrence Flag ,Character indicator for the first occurrence of the maximum severity/intensity within the subject and system organ class \n Example derivation: Sort the data in the required order and flag the first treatment-emergent record for maximum severity within body system for each subject.,2,OCCDS,Perm,Perm,,Y,
DOSEON,Treatment Dose at Record Start,Num,Treatment/Dose ,Dose received at the point in time of the record start date \n Example derivation: \n Obtained from EX.EXDOSE where --STDTC falls between the values of EX.EXSTDTC and EX.EXENDTC,1,OCCDS,Perm,Perm,,,
DOSCUMA,Cumulative Actual Treatment Dose,Num,Treatment/Dose ,Cumulative actual study drug dosage at the point in time of the record start date \n,2,OCCDS,Perm,Perm,,,
DOSEU,Treatment Dose Units,Char,Treatment/Dose ,The units associated with DOSEON and/or DOSCUMA. Conditional on whether DOSEON and/or DOSCUMA are included.,3,OCCDS,Cond,Cond,,(UNIT),
--SER,Serious Event,Char,Adverse Event Descriptive ,XX.--SER,1,OCCDS,Perm,Req,,(NY),
--SEV,Severity/Intensity,Char,Adverse Event Descriptive ,"XX.--SEV \n For SubClass ADVERSE EVENT, conditional on whether the --SEV variable is in the SDTM AE dataset. Note that either --SEV or --TOXGR should be included in SDTM.",2,OCCDS,Perm,Cond,,(AESEV) or (SEVRS),
--SEVN,Severity/Intensity (N),Num,Adverse Event Descriptive ,Code XX.--SEV to numeric \n Low intensity should correspond to low value,3,OCCDS,Perm,Perm,,"1, 2, 3",
ASEV,Analysis Severity/Intensity,Char,Adverse Event Descriptive ,"Apply imputation rules for missing severity of adverse events as specified in the SAP or metadata. May change case of text, such as from all uppercase in --SEV to mixed case in ASEV.",4,OCCDS,Perm,Perm,,,
ASEVN,Analysis Severity/Intensity (N),Num,Adverse Event Descriptive ,Code ASEV to numeric \n Low intensity should correspond to low value,5,OCCDS,Perm,Perm,,"1, 2, 3",
SEVGRy,Pooled Severity Group y,Char,Adverse Event Descriptive ,"Pooled grouping of AE severity for analysis (e.g., mild/moderate, severe)",6,OCCDS,Perm,Perm,,,
SEVGRyN,Pooled Severity Group y (N),Num,Adverse Event Descriptive ,Code SEVGRy to numeric \n Low intensity should correspond to low value,7,OCCDS,Perm,Perm,,,
--REL,Causality,Char,Adverse Event Descriptive ,XX.--REL,8,OCCDS,Perm,Req,,,
--RELN,Causality (N),Num,Adverse Event Descriptive ,Code XX.--REL to numeric \n Low relation should correspond to low value,9,OCCDS,Perm,Perm,,,
AREL,Analysis Causality,Char,Adverse Event Descriptive ,"Apply imputation rules for missing causality of study drug as specified in the SAP or metadata. May change case of text, such as from all uppercase in --REL to mixed case in AREL.",10,OCCDS,Perm,Perm,,,
ARELN,Analysis Causality (N),Num,Adverse Event Descriptive ,Code AREL to numeric,11,OCCDS,Perm,Perm,,,
RELGRy,Pooled Causality Group y,Char,Adverse Event Descriptive ,"Pooled grouping of causality of study drug for analysis (e.g. related, not related)",12,OCCDS,Perm,Perm,,,
RELGRyN,Pooled Causality Group y (N),Num,Adverse Event Descriptive ,Code of RELGRy to numeric \n Low relation should correspond to low value,13,OCCDS,Perm,Perm,,,
--TOXGR,Standard Toxicity Grade,Char,Adverse Event Descriptive ,"XX.--TOXGR \n For SubClass ADVERSE EVENT, conditional on whether the --TOXGR variable is in the SDTM AE dataset. Note that either --SEV or --TOXGR should be included in SDTM.",14,OCCDS,Perm,Cond,,,
--TOXGRN,Standard Toxicity Grade (N),Num,Adverse Event Descriptive ,Code --TOXGR to numeric \n Low toxicity should correspond to low value,15,OCCDS,Perm,Perm,,,
ATOXGR,Analysis Toxicity Grade,Char,Adverse Event Descriptive ,"Toxicity grade for analysis. May be based on --TOXGR or an imputed or assigned value. May change case of text, such as from all uppercase in --TOXGR to mixed case in ATOXGR.",16,OCCDS,Perm,Perm,,,
ATOXGRN,Analysis Toxicity Grade (N),Num,Adverse Event Descriptive ,Code ATOXGR to numeric \n Low toxicity should correspond to low value,17,OCCDS,Perm,Perm,,,
TOXGGRy,Pooled Toxicity Grade Group y,Char,Adverse Event Descriptive ,Pooled grouping of toxicity grade for analysis,18,OCCDS,Perm,Perm,,,
TOXGGRyN,Pooled Toxicity Grade Group y (N),Num,Adverse Event Descriptive ,Code of TOXGGRy to numeric \n Low toxicity should correspond to low value,19,OCCDS,Perm,Perm,,,
--ACN,Action Taken with Study Treatment,Char,Adverse Event Descriptive ,XX.--ACN \n Required if XX.--ACN is present and populated,20,OCCDS,Perm,Cond,,(ACN),
--STAT,Completion Status,Char,Concomitant Medications Descriptive ,XX.--STAT,1,OCCDS,Perm,,,,
--INDC,Indication,Char,Concomitant Medications Descriptive ,XX.--INDC,2,OCCDS,Perm,,,,
--DOSE,Dose per Administration,Num,Concomitant Medications Descriptive ,XX.--DOSE,3,OCCDS,Perm,,,,
--DOSFRM,Dose Form,Char,Concomitant Medications Descriptive ,XX.--DOSFRM,4,OCCDS,Perm,,,,
--DOSRGM,Intended Dose Regimen,Char,Concomitant Medications Descriptive ,XX.--DOSRGM,5,OCCDS,Perm,,,,
--ROUTE,Route of Administration,Char,Concomitant Medications Descriptive ,XX.--ROUTE,6,OCCDS,Perm,,,,
SMQzzNAM,SMQ zz Name,Char,Standardized MedDRA Query ,The Standardized MedDRA Query name. Would be blank for terms that are not in the SMQ. Therefore this variable could be blank for all records if no terms within the study were included in the SMQ. \n Conditional on whether SMQ analysis is done,1,OCCDS,Cond,Cond,,,
SMQzzCD,SMQ zz Code,Num,Standardized MedDRA Query ,The standardized MedDRA queries number code,2,OCCDS,Perm,Perm,,,
SMQzzSC,SMQ zz Scope,Char,Standardized MedDRA Query ,"The search strategy for SMQs can be narrow or broad. The preferred terms that are narrow in scope have high specificity for identifying events of interest, whereas the broad terms have high sensitivity. By definition, all narrow terms are also considered within the broad scope. Therefore, to summarize all broad terms, terms with either narrow or broad would be considered. Will be null for terms that do not meet the criteria. \n Conditional on whether SMQ analysis is done",3,OCCDS,Cond,Cond,,"BROAD, NARROW",
SMQzzSCN,SMQ zz Scope (N),Num,Standardized MedDRA Query ,Will be null for terms that do not meet the criteria,4,OCCDS,Perm,Perm,,"1, 2",
CQzzNAM,Customized Query zz Name,Char,Standardized MedDRA Query ,"The CQ name or name of the adverse event of special interest category based on a grouping of terms. Would be blank for terms that are not in the CQ. \n Conditional on whether CQ analysis is done \n Examples: ""DERMATOLOGICAL EVENTS"" ""CARDIAC EVENTS"", ""IARS (INFUSION ASSOCIATED REACTIONS)""",5,OCCDS,Cond,Cond,,,
ADECODy,Analysis Dictionary-Derived Term y,Char,Standardized MedDRA Query ,"The terms used for the analysis when combining multiple customized query or multiple standardized MedDRA queries and the original MedDRA dictionary terms under 1 variable \n Although designed for MedDRA queries, this variable could be used for other OCCDS analysis needs.",6,OCCDS,Perm,Perm,,,
DECDORGw,PT in Original Dictionary w,Char,Original or Prior MedDRA Coding ,Original preferred term coding of XX.--TERM using MedDRA or other dictionary version X.X,1,OCCDS,Perm,Perm,,,MedDRAw
BDSYORGw,SOC in Original Dictionary w,Char,Original or Prior MedDRA Coding ,Original body system coding of XX.--TERM using MedDRA or other dictionary version X.X,2,OCCDS,Perm,Perm,,,MedDRAw
HLGTORGw,HLGT in Original Dictionary w,Char,Original or Prior MedDRA Coding ,Original HLGT coding of XX.--TERM using MedDRA or other dictionary version X.X,3,OCCDS,Perm,Perm,,,MedDRAw
HLTORGw,HLT in Original Dictionary w,Char,Original or Prior MedDRA Coding ,Original HLT coding of XX.--TERM using MedDRA or other dictionary version X.X,4,OCCDS,Perm,Perm,,,MedDRAw
LLTORGw,LLT in Original Dictionary w,Char,Original or Prior MedDRA Coding ,Original LLT coding of XX.--TERM using MedDRA or other dictionary version X.X,5,OCCDS,Perm,Perm,,,MedDRAw
LLTNORGw,LLT Code in Original Dictionary w,Char,Original or Prior MedDRA Coding ,Original LLT code of XX.--TERM using MedDRA or other dictionary version X.X,6,OCCDS,Perm,Perm,,,MedDRAw
DECDORGw,Standardized Med Name in Orig Dict w,Char,Original or Prior WHO Drug Coding ,Original standardized medication name of CM.CMTRT using WHO Drug version X.X,1,OCCDS,Perm,Perm,,,WHODRUGw
CLASORGw,Medication Class in Orig Dictionary w,Char,Original or Prior WHO Drug Coding ,Original medication class of CM.CMTRT using WHO Drug version X.X,2,OCCDS,Perm,Perm,,,WHODRUGw
CLCDORGw,Medication Class Code in Orig Dict w,Char,Original or Prior WHO Drug Coding ,Original medication class code of CM.CMTRT using WHO Drug version X.X,3,OCCDS,Perm,Perm,,,WHODRUGw
ATyCORGw,ATC Level y Code in Orig Dictionary w,Char,Original or Prior WHO Drug Coding ,Original ATC Level y code of CM.CMTRT using WHO Drug version X.X,4,OCCDS,Perm,Perm,,,WHODRUGw
ATyTORGw,ATC Level y Text in Orig Dictionary w,Char,Original or Prior WHO Drug Coding ,Original ATC Level y text of CM.CMTRT using WHO Drug version X.X,5,OCCDS,Perm,Perm,,,WHODRUGw