"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 ,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"" and ""N""."
--SCONG ,"Congenital Anomaly
or Birth Defect",Char ,"Record
Qualifier","Was the event associated with congenital anomaly or birth defect?
Valid values are ""Y"" and ""N""."
--SDISAB ,"Persist or Signif
Disability/Incapacity",Char ,"Record
Qualifier","Did the event result in persistent or significant
disability/incapacity? Valid values are ""Y"" and ""N""."
--SDTH ,Results in Death ,Char ,"Record
Qualifier","Did the event result in death? Valid values are ""Y"" and ""N""."
--SHOSP ,"Requires or Prolongs
Hospitalization",Char ,"Record
Qualifier","Did the event require or prolong hospitalization? Valid values are
""Y"" and ""N""."
--SLIFE ,Is Life Threatening ,Char ,"Record
Qualifier","Was the event life threatening? Valid values are ""Y"" and ""N""."
--SOD ,"Occurred with
Overdose",Char ,"Record
Qualifier","Did the event occur with an overdose? Valid values are ""Y"" and
""N""."
--SMIE ,"Other Medically
Important Serious
Event",Char ,"Record
Qualifier","Do additional categories for seriousness apply? Valid values are
""Y"" and ""N""."
--CONTRT ,"Concomitant or
Additional Trtmnt
Given",Char ,"Record
Qualifier","Was another treatment given because of the occurrence of the
event? Valid values are ""Y"" and ""N""."
--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."
