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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 SPDEVID Sponsor Device Identifier Char Identifier Perm A sequence of characters used by the sponsor to uniquely identify a specific device. Used to represent a device associated in some way with the adverse event. SPDEVID values are defined in the Device Identifiers (DI) domain.
5 AE AESEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
6 AE AEGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
7 AE AEREFID Reference ID Char Identifier Perm Internal or external identifier such as a serial number on an SAE reporting form.
8 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 CRF page.
9 AE AETERM Reported Term for the Adverse Event Char Topic Req Verbatim name of the event.
10 AE AEMODIFY Modified Reported Term Char Synonym Qualifier Perm If AETERM is modified to facilitate coding, then AEMODIFY will contain the modified text.
11 AE AELLT Lowest Level Term Char MedDRA Variable Qualifier Exp Dictionary-derived text description of the lowest level term.
12 AE AELLTCD Lowest Level Term Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the lowest level term.
13 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.
14 AE AEPTCD Preferred Term Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the preferred term.
15 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 (SOC).
16 AE AEHLTCD High Level Term Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the high level term for the primary SOC.
17 AE AEHLGT High Level Group Term Char MedDRA Variable Qualifier Exp Dictionary-derived text description of the high level group term for the primary SOC.
18 AE AEHLGTCD High Level Group Term Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the high level group term for the primary SOC.
19 AE AECAT Category for Adverse Event Char Grouping Qualifier Perm Used to define a category of related records. Examples: "BLEEDING", "NEUROPSYCHIATRIC".
20 AE AESCAT Subcategory for Adverse Event Char Grouping Qualifier Perm A further categorization of adverse event. Example: "NEUROLOGIC".
21 AE AEPRESP Pre-Specified Adverse Event Char C66742 Variable Qualifier Perm A value of "Y" indicates that this adverse event was prespecified on the CRF. Values are null for spontaneously reported events (i.e., those collected as free-text verbatim terms).
22 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.
23 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.
24 AE AESOC Primary System Organ Class Char MedDRA Variable Qualifier Exp Dictionary-derived text description of the primary SOC. Will be the same as AEBODSYS if the primary SOC was used for analysis.
25 AE AESOCCD Primary System Organ Class Code Num MedDRA Variable Qualifier Exp Dictionary-derived code for the primary SOC. Will be the same as AEBDSYCD if the primary SOC was used for analysis.
26 AE AELOC Location of Event Char C74456 Record Qualifier Perm Describes anatomical location relevant for the event (e.g., "ARM" for skin rash).
27 AE AESEV Severity/Intensity Char C66769 Record Qualifier Perm The severity or intensity of the event. Examples: "MILD", "MODERATE", "SEVERE".
28 AE AESER Serious Event Char C66742 Record Qualifier Exp Is this a serious event? Valid values are "Y" and "N".
29 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" and "NOT APPLICABLE".
30 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".
31 AE AEACNDEV Action Taken with Device Char C111110 Record Qualifier Perm An action taken with a device as the result of the event. The device may or may not be a device under study.
32 AE AEREL Causality Char Record Qualifier Exp Records the investigator's opinion as to the causality of the event to the treatment. ICH does not establish any required or recommended terms for non-device relatedness. ICH E2A and E2B examples include (up-cased here for alignment to SDTM conventions) terms such as "NOT RELATED", "UNLIKELY RELATED", "POSSIBLY RELATED", "RELATED", but these example terms do not establish any conventions or expectations. Controlled terminology may be defined in the future. Check with regulatory authority for population of this variable.
33 AE AERLDEV Relationship of Event to Device Char Record Qualifier Perm A judgment as to the likelihood that the device caused the adverse event. The relationship is to a device identified in the data (i.e., has an SPDEVID). The device may be ancillary or under study. \n Terminology: \n * In the EU, follow the European Commission Guidelines on Medical Devices, Clinical Investigations: SAE Reporting (MEDDEV 2.7/3) (e.g., Not Related, Unlikely, Possible, Probable, Causal Relationship), with device-specific definitions. \n * No required Controlled Terminology in US.
34 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".
35 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".
36 AE AEOUT Outcome of Adverse Event Char C66768 Record Qualifier Perm Description of the outcome of an event.
37 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 or E2B.
38 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".
39 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".
40 AE AESDTH Results in Death Char C66742 Record Qualifier Perm Did the serious event result in death? Valid values are "Y" and "N".
41 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".
42 AE AESLIFE Is Life Threatening Char C66742 Record Qualifier Perm Was the serious event life-threatening? Valid values are "Y" and "N".
43 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 or E2B.
44 AE AESMIE Other Medically Important Serious Event Char C66742 Record Qualifier Perm Do additional categories for seriousness apply? Valid values are "Y" and "N".
45 AE AESINTV Needs Intervention to Prevent Impairment Char C66742 Record Qualifier Perm Records whether medical or surgical intervention was necessary to preclude permanent impairment of a body function, or to prevent permanent damage to a body structure, with either situation suspected to be due to the use of a medical product. This variable is used in conjunction with the other "seriousness" variables (e.g., fatal, life-threatening). It is part of the US federal government definition of a serious adverse event; see 21 CFR Part 803.3(w)(3).
46 AE AEUNANT Unanticipated Adverse Device Effect Char C66742 Record Qualifier Perm Any serious adverse effect on health or safety or any life-threatening problem or death caused by or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), \n or \n any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. (21 CFR Part 812.3(s)). \n This variable applies only to serious AEs and should hold collected data; if the value is derived, it should be held in ADaM.
47 AE AERLPRT Rel of AE to Non-Dev-Rel Study Activity Char Record Qualifier Perm The investigator's opinion as to the causality of the event as related to other protocol-required activities, actions, or assessments (e.g., medication changes, tests/assessments, other procedures). The relationship is to a protocol-specified, non-device-related activity where the device is identified in the data (i.e., has an SPDEVID). The device may be ancillary or under study. \n Terminology: \n * In the EU, follow the European Commission Guidelines on Medical Devices, Clinical Investigations: SAE Reporting (MEDDEV 2.7/3) (e.g., Not Related, Unlikely, Possible, Probable, Causal Relationship), with device-specific definitions. \n * No required Controlled Terminology in US.
48 AE AERLPRC Rel of AE to Device-Related Procedure Char Record Qualifier Perm The investigator's opinion as to the likelihood that the device-related study procedure (e.g., implant/insertion, revision/adjustment, explant/removal) caused the AE. The relationship is to a device-related procedure where the device is identified in the data (i.e., has an SPDEVID). The device may be ancillary or under study. \n Terminology: \n * In the EU, follow the European Commission Guidelines on Medical Devices, Clinical Investigations: SAE Reporting (MEDDEV 2.7/3) (e.g., Not Related, Unlikely, Possible, Probable, Causal Relationship), with device-specific definitions. \n * No required Controlled Terminology in US.
49 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".
50 AE AETOXGR Standard Toxicity Grade Char Record Qualifier Perm Toxicity grade according to a standard toxicity scale (e.g., Common Terminology Criteria for Adverse Events, CTCAE). Sponsors should specify the name of the scale and version used in the metadata (see assumption 7d). If value is from a numeric scale, represent only the number (e.g., "2", not "Grade 2").
51 AE TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the element within the arm.
52 AE EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the adverse event. Examples: "SCREENING", "TREATMENT", "FOLLOW-UP".
53 AE AESTDTC Start Date/Time of Adverse Event Char ISO 8601 datetime or interval Timing Exp Start date/time of the adverse event represented in ISO 8601 character format.
54 AE AEENDTC End Date/Time of Adverse Event Char ISO 8601 datetime or interval Timing Exp End date/time of the adverse event represented in ISO 8601 character format.
55 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.
56 AE AEENDY Study Day of End of Adverse Event Num Timing Perm Study day of end of event relative to the sponsor-defined RFSTDTC.
57 AE AEDUR Duration of Adverse Event Char ISO 8601 duration 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).
58 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. \n Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
59 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. \n Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables.
60 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", "VISIT 2".