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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 AE STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 AE DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 AE USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4 AE AESEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 AE AEGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 AE AEREFID Reference ID Char Identifier Perm Internal or external identifier such as a serial number on an SAE reporting form.
7 AE AESPID Sponsor-Defined Identifier Char Identifier Perm 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.
8 AE AETERM Reported Term for the Adverse Event Char Topic Req Verbatim name of the event.
9 AE AEMODIFY Modified Reported Term Char Synonym Qualifier Perm If AETERM is modified to facilitate coding, then AEMODIFY will contain the modified text.
10 AE AELLT Lowest Level Term Char MedDRA Variable Qualifier Exp Dictionary-derived text description of the Lowest Level Term.
11 AE AELLTCD Lowest Level Term Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the Lowest Level Term.
12 AE AEDECOD Dictionary-Derived Term Char MedDRA Synonym Qualifier Req Dictionary-derived text description of AETERM or AEMODIFY. Equivalent to the Preferred Term (PT 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.
13 AE AEPTCD Preferred Term Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the Preferred Term.
14 AE AEHLT High Level Term Char MedDRA Variable Qualifier Exp Dictionary-derived text description of the High Level Term for the primary System Organ Class.
15 AE AEHLTCD High Level Term Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the High Level Term for the primary System Organ Class.
16 AE AEHLGT High Level Group Term Char MedDRA Variable Qualifier Exp Dictionary-derived text description of the High Level Group Term for the primary System Organ Class.
17 AE AEHLGTCD High Level Group Term Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the High Level Group Term for the primary System Organ Class.
18 AE AECAT Category for Adverse Event Char Grouping Qualifier Perm Used to define a category of related records. Example: "BLEEDING", "NEUROPSYCHIATRIC".
19 AE AESCAT Subcategory for Adverse Event Char Grouping Qualifier Perm A further categorization of adverse event. Example: "NEUROLOGIC".
20 AE AEPRESP Pre-Specified Adverse Event Char C66742 Variable Qualifier Perm 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).
21 AE AEBODSYS Body System or Organ Class Char Record Qualifier Exp 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.
22 AE AEBDSYCD Body System or Organ Class Code Num MedDRA Variable Qualifier Exp 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.
23 AE AESOC Primary System Organ Class Char MedDRA Variable Qualifier Exp Dictionary-derived text description of the primary System Organ Class. Will be the same as AEBODSYS if the primary SOC was used for analysis.
24 AE AESOCCD Primary System Organ Class Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the primary System Organ Class. Will be the same as AEBDSYCD if the primary SOC was used for analysis.
25 AE AELOC Location of Event Char C74456 Record Qualifier Perm Describes anatomical location relevant for the event (e.g., "ARM" for skin rash).
26 AE AESEV Severity/Intensity Char C66769 Record Qualifier Perm The severity or intensity of the event. Examples: "MILD", "MODERATE", "SEVERE".
27 AE AESER Serious Event Char C66742 Record Qualifier Exp Is this a serious event? Valid values are "Y" and "N".
28 AE AEACN Action Taken with Study Treatment Char C66767 Record Qualifier Exp 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".
29 AE AEACNOTH Other Action Taken Char Record Qualifier Perm 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".
30 AE AEREL Causality Char Record Qualifier Exp 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". Controlled Terminology may be defined in the future. Check with regulatory authority for population of this variable.
31 AE AERELNST Relationship to Non-Study Treatment Char Record Qualifier Perm 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".
32 AE AEPATT Pattern of Adverse Event Char Record Qualifier Perm Used to indicate the pattern of the event over time. Examples: "INTERMITTENT", "CONTINUOUS", "SINGLE EVENT".
33 AE AEOUT Outcome of Adverse Event Char C66768 Record Qualifier Perm Description of the outcome of an event.
34 AE AESCAN Involves Cancer Char C66742 Record Qualifier Perm 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.
35 AE AESCONG Congenital Anomaly or Birth Defect Char C66742 Record Qualifier Perm Was the serious event associated with congenital anomaly or birth defect? Valid values are "Y" and "N".
36 AE AESDISAB Persist or Signif Disability/Incapacity Char C66742 Record Qualifier Perm Did the serious event result in persistent or significant disability/incapacity? Valid values are "Y" and "N".
37 AE AESDTH Results in Death Char C66742 Record Qualifier Perm Did the serious event result in death? Valid values are "Y" and "N".
38 AE AESHOSP Requires or Prolongs Hospitalization Char C66742 Record Qualifier Perm Did the serious event require or prolong hospitalization? Valid values are "Y" and "N".
39 AE AESLIFE Is Life Threatening Char C66742 Record Qualifier Perm Was the serious event life threatening? Valid values are "Y" and "N".
40 AE AESOD Occurred with Overdose Char C66742 Record Qualifier Perm 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.
41 AE AESMIE Other Medically Important Serious Event Char C66742 Record Qualifier Perm Do additional categories for seriousness apply? Valid values are "Y" and "N".
42 AE AECONTRT Concomitant or Additional Trtmnt Given Char C66742 Record Qualifier Perm Was another treatment given because of the occurrence of the event? Valid values are "Y" and "N".
43 AE AETOXGR Standard Toxicity Grade Char Record Qualifier Perm 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").
44 AE TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the Element within the Arm.
45 AE EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the adverse event. Examples: "SCREENING", "TREATMENT", "FOLLOW-UP".
46 AE AESTDTC Start Date/Time of Adverse Event Char ISO 8601 Timing Exp Start date/time of the adverse event represented in ISO 8601 character format.
47 AE AEENDTC End Date/Time of Adverse Event Char ISO 8601 Timing Exp End date/time of the adverse event represented in ISO 8601 character format.
48 AE AESTDY Study Day of Start of Adverse Event Num Timing Perm Study day of start of adverse event relative to the sponsor-defined RFSTDTC.
49 AE AEENDY Study Day of End of Adverse Event Num Timing Perm Study day of end of event relative to the sponsor-defined RFSTDTC.
50 AE AEDUR Duration of Adverse Event Char ISO 8601 Timing Perm 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).
51 AE AEENRF End Relative to Reference Period Char C66728 Timing Perm Describes the end of the event relative to the sponsor-defined reference period. The sponsor-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.
52 AE AEENRTPT End Relative to Reference Time Point Char C66728 Timing Perm 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.
53 AE AEENTPT End Reference Time Point Char Timing Perm Description of date/time in ISO 8601 character format of the reference point referred to by AEENRTPT. Examples: "2003-12-25" or "VISIT 2".