Variable Name,Variable Label,Type,Role,Description
Topic Variable,,,,
--TERM,Reported Term,Char,Topic,"Topic variable for an event observation, which is the verbatim or pre-specified name of the event."
Qualifier Variables,,,,
--MODIFY,Modified Reported Term,Char,Synonym Qualifier of --TERM,"If the value for --TERM is modified for coding purposes, then the modified text is placed here."
--LLT,Lowest Level Term,Char,Variable Qualifier of --TERM,MedDRA Lowest Level Term.
--LLTCD,Lowest Level Term Code,Num,Variable Qualifier of --LLT,MedDRA Lowest Level Term code.
--DECOD,Dictionary-Derived Term,Char,Synonym Qualifier of --TERM,"Dictionary or sponsor-defined derived text description of the topic variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA)."
--PTCD,Preferred Term Code,Num,Variable Qualifier of --DECOD,MedDRA Preferred Term code.
--HLT,High Level Term,Char,Variable Qualifier of --TERM,MedDRA High Level Term from the primary path.
--HLTCD,High Level Term Code,Num,Variable Qualifier of --HLT,MedDRA High Level Term code from the primary path.
--HLGT,High Level Group Term,Char,Variable Qualifier of --TERM,MedDRA High Level Group Term from the primary path.
--HLGTCD,High Level Group Term Code,Num,Variable Qualifier of --HLGT,MedDRA High Level Group Term code from the primary path.
--CAT,Category,Char,Grouping Qualifier,Used to define a category of topic-variable values.
--SCAT,Subcategory,Char,Grouping Qualifier,Used to define a further categorization of --CAT values.
--PRESP,Pre-Specified,Char,Variable Qualifier of --TERM,"Used to indicate whether the event described by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously reported events."
--OCCUR,Occurrence Indicator,Char,Record Qualifier,Used to record whether a pre-specified event occurred when information about the occurrence of a specific event is solicited.
--STAT,Completion Status,Char,Record Qualifier,Used to indicate when a question about the occurrence of a pre-specified event was not answered. Should be null or have a value of NOT DONE.
--REASND,Reason Not Done,Char,Record Qualifier,"Reason not done. Used in conjunction with --STAT when its value is ""NOT DONE""."
--BODSYS,Body System or Organ Class,Char,Record Qualifier,"Body system or system organ class assigned for analysis from a standard hierarchy (e.g., MedDRA) associated with an event. Example: ""GASTROINTESTINAL DISORDERS""."
--BDSYCD,Body System or Organ Class Code,Num,Variable Qualifier of --BODSYS,MedDRA System Organ Class code corresponding to --BODSYS assigned for analysis.
--SOC,Primary System Organ Class,Char,Variable Qualifier of --TERM,MedDRA primary System Organ Class associated with the event.
--SOCCD,Primary System Organ Class Code,Num,Variable Qualifier of --SOC,MedDRA primary System Organ Class code.
--LOC,Location of Event,Char,Record Qualifier,"Describes anatomical location relevant for the event. Example: ""ARM"" for skin rash."
--LAT,Laterality,Char,Variable Qualifier of --LOC,"Qualifier for anatomical location further detailing laterality. Examples: ""RIGHT"", ""LEFT"", ""BILATERAL""."
--DIR,Directionality,Char,Variable Qualifier of --LOC,"Qualifier for anatomical location further detailing directionality. Examples: ""ANTERIOR"", ""LOWER"", ""PROXIMAL""."
--PORTOT,Portion or Totality,Char,Variable Qualifier of --LOC,"Qualifier for anatomical location further detailing the distribution, which means arrangement of, apportioning of. Examples: ""ENTIRE"", ""SINGLE"", ""SEGMENT"", ""MANY""."
--PARTY,Accountable Party,Char,Record Qualifier,"Party accountable for the transferable object (e.g., device, specimen) as a result of the activity performed in the associated --TERM variable. The party could be an individual (e.g., subject), an organization (e.g., sponsor), or a location that is a proxy for an individual or organization (e.g., site). It is usually a somewhat general term that is further identified in the --PRTYID variable."
--PRTYID,Identification of Accountable Party,Char,Record Qualifier,"Identification of the specific party accountable for the transferable object (e.g., device, specimen) after the action in --TERM is taken. Used in conjunction with --PARTY."
--SEV,Severity/Intensity,Char,Record Qualifier,"The severity or intensity of the event. Examples: ""MILD"", ""MODERATE"", ""SEVERE""."
--SER,Serious Event,Char,Record Qualifier,"Is this is a serious event? Valid values are ""Y"" and ""N""."
--ACN,Action Taken with Study Treatment,Char,Record Qualifier,"Describes changes made to the study treatment as a result of the event. Examples: ""DOSE INCREASED"", ""DOSE NOT CHANGED""."
--ACNOTH,Other Action Taken,Char,Record Qualifier,Describes other actions taken as a result of the event that are unrelated to dose adjustments of study treatment.
--ACNDEV,Action Taken with Device,Char,Record Qualifier,"Action taken with respect to a device in a study, which may or may not be the device under study."
--REL,Causality,Char,Record Qualifier,"Records the investigator's opinion as to the causality of the event to the treatment. ICH E2A and E2B examples include ""NOT RELATED"", ""UNLIKELY RELATED"", ""POSSIBLY RELATED"", ""RELATED""."
--RELNST,Relationship to Non-Study Treatment,Char,Record Qualifier,"An opinion as to whether the event may have been due to a treatment other than study drug. Example: ""MORE LIKELY RELATED TO ASPIRIN USE""."
--PATT,Pattern of Event,Char,Record Qualifier,"Used to indicate the pattern of the event over time. Examples: ""INTERMITTENT"", ""CONTINUOUS"", ""SINGLE EVENT""."
--OUT,Outcome of Event,Char,Record Qualifier,"Description of the outcome of an event. Examples: ""RECOVERED/RESOLVED"", ""FATAL""."
--SCAN,Involves Cancer,Char,Record Qualifier,"Was the event associated with the development of cancer? Valid values are ""Y"", ""N"", and null."
--SCONG,Congenital Anomaly or Birth Defect,Char,Record Qualifier,"Was the event associated with congenital anomaly or birth defect? Valid values are ""Y"", ""N"", and null."
--SDISAB,Persist or Signif Disability/Incapacity,Char,Record Qualifier,"Did the event result in persistent or significant disability/incapacity? Valid values are ""Y"", ""N"", and null."
--SDTH,Results in Death,Char,Record Qualifier,"Did the event result in death? Valid values are ""Y"", ""N"", and null."
--SHOSP,Requires or Prolongs Hospitalization,Char,Record Qualifier,"Did the event require or prolong hospitalization? Valid values are ""Y"", ""N"", and null."
--SLIFE,Is Life Threatening,Char,Record Qualifier,"Was the event life threatening? Valid values are ""Y"", ""N"", and null."
--SOD,Occurred with Overdose,Char,Record Qualifier,"Did the event occur with an overdose? Valid values are ""Y"", ""N"", and null."
--SMIE,Other Medically Important Serious Event,Char,Record Qualifier,"Do additional categories for seriousness apply? Valid values are ""Y"", ""N"", and null."
--CONTRT,Concomitant or Additional Trtmnt Given,Char,Record Qualifier,"Was another treatment given because of the occurrence of the event? Valid values are ""Y"", ""N"", and null."
--TOX,Toxicity,Char,Variable Qualifier of --TOXGR,"Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: ""HYPERCALCEMIA"", ""HYPOCALCEMIA"". Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define-XML document."
--TOXGR,Toxicity Grade,Char,Record Qualifier,Records toxicity grade using a standard toxicity scale (such as the NCI CTCAE). Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define.XML document.
--USCHFL,Unscheduled Flag,Char,Record Qualifier,"Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. Not to be used with human clinical trials. This variable would not be needed when information on planned assessments is provided, such as when the Trial Visits (TV) and Subject Visits (SV) domains are used."
