Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 AE 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 AE 2 DOMAIN Domain Abbreviation Char AE Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 AE 3 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
SDTMIG 3.3 AE 4 AESEQ Sequence Number Num Identifier Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 AE 5 AEGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 AE 6 AEREFID Reference ID Char Identifier Internal or external identifier such as a serial number on an SAE reporting form. Perm
SDTMIG 3.3 AE 7 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
SDTMIG 3.3 AE 8 AETERM Reported Term for the Adverse Event Char Topic Verbatim name of the event. Req
SDTMIG 3.3 AE 9 AEMODIFY Modified Reported Term Char Synonym Qualifier If AETERM is modified to facilitate coding, then AEMODIFY will contain the modified text. Perm
SDTMIG 3.3 AE 10 AELLT Lowest Level Term Char MedDRA Variable Qualifier Dictionary-derived text description of the Lowest Level Term. Exp
SDTMIG 3.3 AE 11 AELLTCD Lowest Level Term Code Num MedDRA Variable Qualifier Dictionary-derived code for the Lowest Level Term. Exp
SDTMIG 3.3 AE 12 AEDECOD Dictionary-Derived Term Char MedDRA Synonym Qualifier 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. Req
SDTMIG 3.3 AE 13 AEPTCD Preferred Term Code Num MedDRA Variable Qualifier Dictionary-derived code for the Preferred Term. Exp
SDTMIG 3.3 AE 14 AEHLT High Level Term Char MedDRA Variable Qualifier Dictionary-derived text description of the High Level Term for the primary System Organ Class. Exp
SDTMIG 3.3 AE 15 AEHLTCD High Level Term Code Num MedDRA Variable Qualifier Dictionary-derived code for the High Level Term for the primary System Organ Class. Exp
SDTMIG 3.3 AE 16 AEHLGT High Level Group Term Char MedDRA Variable Qualifier Dictionary-derived text description of the High Level Group Term for the primary System Organ Class. Exp
SDTMIG 3.3 AE 17 AEHLGTCD High Level Group Term Code Num MedDRA Variable Qualifier Dictionary-derived code for the High Level Group Term for the primary System Organ Class. Exp
SDTMIG 3.3 AE 18 AECAT Category for Adverse Event Char Grouping Qualifier Used to define a category of related records. Example: "BLEEDING", "NEUROPSYCHIATRIC". Perm
SDTMIG 3.3 AE 19 AESCAT Subcategory for Adverse Event Char Grouping Qualifier A further categorization of adverse event. Example: "NEUROLOGIC". Perm
SDTMIG 3.3 AE 20 AEPRESP Pre-Specified Adverse Event Char (NY) 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
SDTMIG 3.3 AE 21 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
SDTMIG 3.3 AE 22 AEBDSYCD Body System or Organ Class Code Num MedDRA 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
SDTMIG 3.3 AE 23 AESOC Primary System Organ Class Char MedDRA 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
SDTMIG 3.3 AE 24 AESOCCD Primary System Organ Class Code Num MedDRA 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
SDTMIG 3.3 AE 25 AELOC Location of Event Char (LOC) Record Qualifier Describes anatomical location relevant for the event (e.g., "ARM" for skin rash). Perm
SDTMIG 3.3 AE 26 AESEV Severity/Intensity Char (AESEV) Record Qualifier The severity or intensity of the event. Examples: "MILD", "MODERATE", "SEVERE". Perm
SDTMIG 3.3 AE 27 AESER Serious Event Char (NY) Record Qualifier Is this a serious event? Valid values are "Y" and "N". Exp
SDTMIG 3.3 AE 28 AEACN Action Taken with Study Treatment Char (ACN) 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
SDTMIG 3.3 AE 29 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
SDTMIG 3.3 AE 30 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", "UNLIKELY RELATED", "POSSIBLY RELATED", "RELATED". Controlled Terminology may be defined in the future. Check with regulatory authority for population of this variable. Exp
SDTMIG 3.3 AE 31 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
SDTMIG 3.3 AE 32 AEPATT Pattern of Adverse Event Char Record Qualifier Used to indicate the pattern of the event over time. Examples: "INTERMITTENT", "CONTINUOUS", "SINGLE EVENT". Perm
SDTMIG 3.3 AE 33 AEOUT Outcome of Adverse Event Char (OUT) Record Qualifier Description of the outcome of an event. Perm
SDTMIG 3.3 AE 34 AESCAN Involves Cancer Char (NY) 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
SDTMIG 3.3 AE 35 AESCONG Congenital Anomaly or Birth Defect Char (NY) Record Qualifier Was the serious event associated with congenital anomaly or birth defect? Valid values are "Y" and "N". Perm
SDTMIG 3.3 AE 36 AESDISAB Persist or Signif Disability/Incapacity Char (NY) Record Qualifier Did the serious event result in persistent or significant disability/incapacity? Valid values are "Y" and "N". Perm
SDTMIG 3.3 AE 37 AESDTH Results in Death Char (NY) Record Qualifier Did the serious event result in death? Valid values are "Y" and "N". Perm
SDTMIG 3.3 AE 38 AESHOSP Requires or Prolongs Hospitalization Char (NY) Record Qualifier Did the serious event require or prolong hospitalization? Valid values are "Y" and "N". Perm
SDTMIG 3.3 AE 39 AESLIFE Is Life Threatening Char (NY) Record Qualifier Was the serious event life threatening? Valid values are "Y" and "N". Perm
SDTMIG 3.3 AE 40 AESOD Occurred with Overdose Char (NY) 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
SDTMIG 3.3 AE 41 AESMIE Other Medically Important Serious Event Char (NY) Record Qualifier Do additional categories for seriousness apply? Valid values are "Y" and "N". Perm
SDTMIG 3.3 AE 42 AECONTRT Concomitant or Additional Trtmnt Given Char (NY) Record Qualifier Was another treatment given because of the occurrence of the event? Valid values are "Y" and "N". Perm
SDTMIG 3.3 AE 43 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
SDTMIG 3.3 AE 44 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm. Perm
SDTMIG 3.3 AE 45 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the adverse event. Examples: "SCREENING", "TREATMENT", "FOLLOW-UP". Perm
SDTMIG 3.3 AE 46 AESTDTC Start Date/Time of Adverse Event Char ISO 8601 Timing Start date/time of the adverse event represented in ISO 8601 character format. Exp
SDTMIG 3.3 AE 47 AEENDTC End Date/Time of Adverse Event Char ISO 8601 Timing End date/time of the adverse event represented in ISO 8601 character format. Exp
SDTMIG 3.3 AE 48 AESTDY Study Day of Start of Adverse Event Num Timing Study day of start of adverse event relative to the sponsor-defined RFSTDTC. Perm
SDTMIG 3.3 AE 49 AEENDY Study Day of End of Adverse Event Num Timing Study day of end of event relative to the sponsor-defined RFSTDTC. Perm
SDTMIG 3.3 AE 50 AEDUR Duration of Adverse Event Char ISO 8601 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
SDTMIG 3.3 AE 51 AEENRF End Relative to Reference Period Char (STENRF) Timing 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. Perm
SDTMIG 3.3 AE 52 AEENRTPT End Relative to Reference Time Point Char (STENRF) 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
SDTMIG 3.3 AE 53 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