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For the SubClass ADVERSE EVENT, it is required that all levels of terms for the primary path in the MedDRA hierarchy—System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Lowest Level Term (LLT), and Preferred Term (PT)—be included. For other OCCDS datasets, these variables are recommended (they are frequently useful in further analyses of events), but not required.
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Variable Name
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Variable Label
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Type
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Codelist
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Controlled Terms
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Core
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SubClass ADVERSE EVENT Core
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CDISC Notes
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--TERM
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Reported Term
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Char
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Req
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Req
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Copied from XX.--TERM
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.
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--DECOD
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Dictionary-Derived Term
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Char
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MedDRA
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Cond
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Req
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Copied from XX.--DECOD
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.
Conditional on whether coded and used for analysis. Required for adverse event data.
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--BODSYS
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Body System or Organ Class
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Char
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MedDRA
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Cond
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Req
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Copied from XX.--BODSYS
Include the dictionary version in the metadata.
Conditional on whether coded and used for analysis. Required for adverse event data.
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--BDSYCD
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Body System or Organ Class Code
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Num
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MedDRA
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Perm
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Req
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Copied from XX.--BDSYCD or the supplemental qualifier
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata.
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--LLT
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Lowest Level Term
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Char
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MedDRA
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Cond
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Req
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Copied from XX.-- LLT or the supplemental qualifier Include the dictionary version in the metadata.
Conditional on whether coded and used for analysis.
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--LLTCD
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Lowest Level Term Code
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Num
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MedDRA
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Perm
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Req
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Copied from XX.--LLTCD or the supplemental qualifier Include the dictionary version in the metadata.
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--PTCD
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Preferred Term Code
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Num
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MedDRA
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Perm
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Req
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Copied from XX.--PTCD or the supplemental qualifier Include the dictionary version in the metadata.
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--HLT
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High Level Term
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Char
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MedDRA
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Cond
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Req
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Copied from XX.--HLT or the supplemental qualifier Include the dictionary version in the metadata.
Conditional on whether used for analysis.
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--HLTCD
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High Level Term Code
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Num
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MedDRA
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Perm
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Req
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Copied from XX.--HLTCD or the supplemental qualifier Include the dictionary version in the metadata.
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--HLGT
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High Level Group Term
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Char
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MedDRA
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Cond
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Req
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Copied from XX.--HLGT or the supplemental qualifier Include the dictionary version in the metadata.
Conditional on whether used for analysis.
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-‑HLGTCD
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High Level Group Term Code
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Num
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MedDRA
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Perm
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Req
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Copied from XX.--HLGTCD or the supplemental qualifier Include the dictionary version in the metadata.
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--SOC
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Primary System Organ Class
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Char
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MedDRA
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Cond
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Req
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Copied from XX.--SOC or the supplemental qualifier Include the dictionary version in the metadata.
Conditional on whether a secondary SOC was used for analysis.
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--SOCCD
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Primary System Organ Class Code
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Num
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MedDRA
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Perm
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Req
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