| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
Identifier |
Two-character abbreviation for the domain. |
Req |
| USUBJID |
Unique Subject Identifier |
Char |
Identifier |
Identifier used to uniquely identify a subject across all
studies for all applications or submissions involving the product. |
Req |
| AESEQ |
Sequence Number |
Num |
Identifier |
Sequence number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| AEGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a single
domain for a subject. |
Perm |
| AEREFID |
Reference ID |
Char |
Identifier |
Internal or external identifier such as a serial number on
an SAE reporting form. |
Perm |
| AESPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined identifier. It may be preprinted on the CRF
as an explicit line identifier or defined in the sponsor's
operational database. Example: Line number on an Adverse Events
page. |
Perm |
| AETERM |
Reported Term for the Adverse Event |
Char |
Topic |
Verbatim name of the event. |
Req |
| AEMODIFY |
Modified Reported Term |
Char |
Synonym Qualifier |
If AETERM is modified to facilitate coding, then AEMODIFY
will contain the modified text. |
Perm |
| AELLT |
Lowest Level Term |
Char |
Variable Qualifier |
Dictionary-derived text description of the Lowest Level
Term. |
Exp |
| AELLTCD |
Lowest Level Term Code |
Num |
Variable Qualifier |
Dictionary-derived code for the Lowest Level Term. |
Exp |
| AEDECOD |
Dictionary-Derived Term |
Char |
Synonym Qualifier |
Dictionary-derived text description of AETERM or AEMODIFY.
Equivalent to the Preferred Term (PT |
Req |
| |
|
|
|
in MedDRA). The sponsor is expected to provide the
dictionary name and version used to map the terms utilizing the
external codelist element in the Define-XML document. |
|
| AEPTCD |
Preferred Term Code |
Num |
Variable Qualifier |
Dictionary-derived code for the Preferred Term. |
Exp |
| AEHLT |
High Level Term |
Char |
Variable Qualifier |
Dictionary-derived text description of the High Level Term
for the primary System Organ Class. |
Exp |
| AEHLTCD |
High Level Term Code |
Num |
Variable Qualifier |
Dictionary-derived code for the High Level Term for the
primary System Organ Class. |
Exp |
| AEHLGT |
High Level Group Term |
Char |
Variable Qualifier |
Dictionary-derived text description of the High Level Group
Term for the primary System Organ Class. |
Exp |
| AEHLGTCD |
High Level Group Term Code |
Num |
Variable Qualifier |
Dictionary-derived code for the High Level Group Term for
the primary System Organ Class. |
Exp |
| AECAT |
Category for Adverse Event |
Char |
Grouping Qualifier |
Used to define a category of related records. Example:
"BLEEDING", "NEUROPSYCHIATRIC". |
Perm |
| AESCAT |
Subcategory for Adverse Event |
Char |
Grouping Qualifier |
A further categorization of adverse event. Example:
"NEUROLOGIC". |
Perm |
| AEPRESP |
Pre-Specified Adverse Event |
Char |
Variable Qualifier |
A value of "Y" indicates that this adverse event was
pre-specified on the CRF. Values are null for spontaneously reported
events (i.e., those collected as free-text verbatim terms). |
Perm |
| AEBODSYS |
Body System or Organ Class |
Char |
Record Qualifier |
Dictionary derived. Body system or organ class used by the
sponsor from the coding dictionary (e.g., MedDRA). When using a
multi-axial dictionary such as MedDRA, this should contain the SOC
used for the sponsor's analyses and summary tables, which may not
necessarily be the primary SOC. |
Exp |
| AEBDSYCD |
Body System or Organ Class Code |
Num |
Variable Qualifier |
Dictionary derived. Code for the body system or organ class
used by the sponsor. When using a multi-axial dictionary such as
MedDRA, this should contain the SOC used for the sponsor's analyses
and summary tables, which may not necessarily be the primary SOC. |
Exp |
| AESOC |
Primary System Organ Class |
Char |
Variable Qualifier |
Dictionary-derived text description of the primary System
Organ Class. Will be the same as AEBODSYS if the primary SOC was
used for analysis. |
Exp |
| AESOCCD |
Primary System Organ Class Code |
Num |
Variable Qualifier |
Dictionary-derived code for the primary System Organ Class.
Will be the same as AEBDSYCD if the primary SOC was used for
analysis. |
Exp |
| AELOC |
Location of Event |
Char |
Record Qualifier |
Describes anatomical location relevant for the event (e.g.,
"ARM" for skin rash). |
Perm |
| AESEV |
Severity/Intensity |
Char |
Record Qualifier |
The severity or intensity of the event. Examples: "MILD",
"MODERATE", "SEVERE". |
Perm |
| AESER |
Serious Event |
Char |
Record Qualifier |
Is this a serious event? Valid values are "Y" and "N". |
Exp |
| AEACN |
Action Taken with Study Treatment |
Char |
Record Qualifier |
Describes changes to the study treatment as a result of the
event. AEACN is specifically for the relationship to study
treatment. AEACNOTH is for actions unrelated to dose adjustments of
study treatment. Examples of AEACN values include ICH E2B values:
"DRUG WITHDRAWN", "DOSE REDUCED", "DOSE INCREASED", "DOSE NOT
CHANGED", "UNKNOWN" or "NOT APPLICABLE". |
Exp |
| AEACNOTH |
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. Usually
reported as free text. Example: "TREATMENT UNBLINDED. PRIMARY CARE
PHYSICIAN NOTIFIED". |
Perm |
| AEREL |
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", |
Exp |
| |
|
|
|
UNLIKELY RELATED, "POSSIBLY RELATED", "RELATED". Controlled
Terminology may be defined in the future. Check with regulatory
authority for population of this variable. |
|
| AERELNST |
Relationship to Non-Study Treatment |
Char |
Record Qualifier |
Records the investigator's opinion as to whether the event
may have been due to a treatment other than study drug. May be
reported as free text. Example: "MORE LIKELY RELATED TO ASPIRIN
USE". |
Perm |
| AEPATT |
Pattern of Adverse Event |
Char |
Record Qualifier |
Used to indicate the pattern of the event over time.
Examples: "INTERMITTENT", "CONTINUOUS", "SINGLE EVENT". |
Perm |
| AEOUT |
Outcome of Adverse Event |
Char |
Record Qualifier |
Description of the outcome of an event. |
Perm |
| AESCAN |
Involves Cancer |
Char |
Record Qualifier |
Was the serious event associated with the development of
cancer? Valid values are "Y" and "N". This is a legacy seriousness
criterion. It is not included in ICH E2A. |
Perm |
| AESCONG |
Congenital Anomaly or Birth Defect |
Char |
Record Qualifier |
Was the serious event associated with congenital anomaly or
birth defect? Valid values are "Y" and "N". |
Perm |
| AESDISAB |
Persist or Signif Disability/Incapacity |
Char |
Record Qualifier |
Did the serious event result in persistent or significant
disability/incapacity? Valid values are "Y" and "N". |
Perm |
| AESDTH |
Results in Death |
Char |
Record Qualifier |
Did the serious event result in death? Valid values are "Y"
and "N". |
Perm |
| AESHOSP |
Requires or Prolongs Hospitalization |
Char |
Record Qualifier |
Did the serious event require or prolong hospitalization?
Valid values are "Y" and "N". |
Perm |
| AESLIFE |
Is Life Threatening |
Char |
Record Qualifier |
Was the serious event life threatening? Valid values are "Y"
and "N". |
Perm |
| AESOD |
Occurred with Overdose |
Char |
Record Qualifier |
Did the serious event occur with an overdose? Valid values
are "Y" and "N". This is a legacy seriousness criterion. It is not
included in ICH E2A. |
Perm |
| AESMIE |
Other Medically Important Serious Event |
Char |
Record Qualifier |
Do additional categories for seriousness apply? Valid values
are "Y" and "N". |
Perm |
| AECONTRT |
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". |
Perm |
| AETOXGR |
Standard Toxicity Grade |
Char |
Record Qualifier |
Toxicity grade according to a standard toxicity scale such
as Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Sponsor should specify name of the scale and version used in the
metadata (see Assumption 6d). If value is from a numeric scale,
represent only the number (e.g., "2" and not "Grade 2"). |
Perm |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the start date/time of the adverse
event. Examples: "SCREENING", "TREATMENT", "FOLLOW-UP". |
Perm |
| AESTDTC |
Start Date/Time of Adverse Event |
Char |
Timing |
Start date/time of the adverse event represented in ISO 8601
character format. |
Exp |
| AEENDTC |
End Date/Time of Adverse Event |
Char |
Timing |
End date/time of the adverse event represented in ISO 8601
character format. |
Exp |
| AESTDY |
Study Day of Start of Adverse Event |
Num |
Timing |
Study day of start of adverse event relative to the
sponsor-defined RFSTDTC. |
Perm |
| AEENDY |
Study Day of End of Adverse Event |
Num |
Timing |
Study day of end of event relative to the sponsor-defined
RFSTDTC. |
Perm |
| AEDUR |
Duration of Adverse Event |
Char |
Timing |
Collected duration and unit of an adverse event. Used only
if collected on the CRF and not derived from start and end
date/times. Example: "P1DT2H" (for 1 day, 2 hours). |
Perm |
| AEENRF |
End Relative to Reference Period |
Char |
Timing |
Describes the end of the event relative to the
sponsor-defined reference period. The sponsor- |
Perm |
| |
|
|
|
defined reference period is a continuous period of time
defined by a discrete starting point (RFSTDTC) and a discrete ending
point (RFENDTC) of the trial. Not all values of the codelist are
allowable for this variable. See Section 4.4.7, Use of Relative
Timing Variables. |
|
| AEENRTPT |
End Relative to Reference Time Point |
Char |
Timing |
Identifies the end of the event as being before or after the
reference time point defined by variable AEENTPT. Not all values of
the codelist are allowable for this variable. See Section 4.4.7, Use
of Relative Timing Variables. |
Perm |
| AEENTPT |
End Reference Time Point |
Char |
Timing |
Description of date/time in ISO 8601 character format of the
reference point referred to by AEENRTPT. Examples: "2003-12-25" or
"VISIT 2". |
Perm |