Adverse Experiences (AE)

ae.xpt, Adverse Events — Events. One record per adverse event per subject, Tabulation.

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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Variable Name	Variable Label	Type	Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	CM	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
CMSEQ	Sequence Number	Num		Identifier	Sequence number to ensure uniqueness of subject records within a domain. May be any valid number.	Req
CMGRPID	Group ID	Char		Identifier	Used to tie together a block of related records in a single domain for a subject.	Perm
CMSPID	Applicant-Defined Identifier	Char		Identifier	Applicant-defined reference number. Example: a number preprinted on the CRF as an explicit line identifier or record identifier defined in the applicant's operational database. Example: line number on a concomitant medication page.	Perm
CMTRT	Reported Name of Drug, Med, or Therapy	Char		Topic	Verbatim medication name that is either preprinted or collected on a CRF.	Req
CMMODIFY	Modified Reported Name	Char		Synonym Qualifier	If CMTRT is modified to facilitate coding, then CMMODIFY will contain the modified text.	Perm
CMDECOD	Standardized Medication Name	Char		Synonym Qualifier	Standardized or dictionary-derived text description of CMTRT or CMMODIFY. Equivalent to the generic drug name in WHO Drug. If an intervention term does not have a decode value in the dictionary, then CMDECOD will be left blank.	Perm
CMCAT	Category for Medication	Char		Grouping Qualifier	Used to define a category of interventions (e.g., medications/treatments/products). Examples: "PRIOR", "CONCOMITANT", "ANTI-CANCER MEDICATION", "GENERAL CONMED".	Perm
CMSCAT	Subcategory for Medication	Char		Grouping Qualifier	A further categorization of interventions (e.g., medications/treatments/products). Examples: "CHEMOTHERAPY", "HORMONAL THERAPY", "ALTERNATIVE THERAPY".	Perm
CMPRESP	CM Pre-specified	Char	(NY)	Variable Qualifier	Used to indicate whether ("Y"/null) information about the use of a specific medication was solicited on the CRF.	Perm
CMOCCUR	CM Occurrence	Char	(NY)	Record Qualifier	When the use of a specific medication is solicited. CMOCCUR is used to indicate whether ("Y"/"N") use of the medication occurred. Values are null for medications not specifically solicited.	Perm
CMSTAT	Completion Status	Char	(ND)	Record Qualifier	Used to indicate that a question about the occurrence of a prespecified intervention was not answered. Should be null or have a value of "NOT DONE".	Perm
CMREASND	Reason Medication Not Collected	Char		Record Qualifier	Reason not done. Used in conjunction with CMSTAT when value is "NOT DONE".	Perm
CMINDC	Indication	Char		Record Qualifier	Denotes why a medication was taken or administered. Examples: "NAUSEA", "HYPERTENSION".	Perm
CMCLAS	Medication Class	Char		Variable Qualifier	Drug class. May be obtained from coding. When coding to a single class, populate with class value. If using a dictionary and coding to multiple classes, then populate multiple values per TIG guidance or omit CMCLAS.	Perm
CMCLASCD	Medication Class Code	Char		Variable Qualifier	Class code corresponding to CMCLAS. Drug class. May be obtained from coding. When coding to a single class, populate with class code. If using a dictionary and coding to multiple classes, then populate multiple values per TIG guidance or omit CMCLASCD.	Perm
CMDOSE	Dose per Administration	Num		Record Qualifier	Amount of CMTRT given. Not populated when CMDOSTXT is populated.	Perm
CMDOSTXT	Dose Description	Char		Record Qualifier	Dosing amounts or a range of dosing information collected in text form. Units may be stored in CMDOSU. Examples: "200-400", "15-20". Not populated when CMDOSE is populated.	Perm
CMDOSU	Dose Units	Char	(UNIT)	Variable Qualifier	Units for CMDOSE, CMDOSTOT, or CMDOSTXT. Examples: "ng", "mg", "mg/kg".	Perm
CMDOSFRM	Dose Form	Char	(FRM)	Variable Qualifier	Dose form for CMTRT. Examples: "TABLET", "LOTION".	Perm
CMDOSFRQ	Dosing Frequency per Interval	Char	(FREQ)	Record Qualifier	Usually expressed as the number of repeated administrations of CMDOSE within a specific time period. Examples: "BID" (twice daily), "Q12H" (every 12 hours).	Perm
CMDOSTOT	Total Daily Dose	Num		Record Qualifier	Total daily dose of CMTRT using the units in CMDOSU. Used when dosing is collected as total daily dose. Total dose over a period other than day could be recorded in a separate supplemental qualifier variable.	Perm
CMDOSRGM	Intended Dose Regimen	Char		Record Qualifier	Text description of the (intended) schedule or regimen for the Intervention. Example: "TWO WEEKS ON, TWO WEEKS OFF".	Perm
CMROUTE	Route of Administration	Char	(ROUTE)	Variable Qualifier	Route of administration for the intervention. Examples: "ORAL", "INTRAVENOUS".	Perm
CMADJ	Reason for Dose Adjustment	Char		Record Qualifier	Describes reason or explanation of why a dose is adjusted. Examples: "ADVERSE EVENT", "INSUFFICIENT RESPONSE", "NON-MEDICAL REASON".	Perm
CMRSDISC	Reason the Intervention Was Discontinued	Char		Record Qualifier	When dosing of a treatment is recorded over multiple successive records, this variable is applicable only for the (chronologically) last record for the treatment.	Perm
TAETORD	Planned Order of Element within Arm	Num		Timing	Number that gives the planned order of the element within the arm for the element in which the medication administration started. Null for medications that started before study participation.	Perm
EPOCH	Epoch	Char	(EPOCH)	Timing	Epoch associated with the start date/time of the medication administration. Null for medications that started before study participation.	Perm
CMSTDTC	Start Date/Time of Medication	Char	ISO 8601 datetime or interval	Timing	Start date/time of the medication administration represented in ISO 8601 character format.	Perm
CMENDTC	End Date/Time of Medication	Char	ISO 8601 datetime or interval	Timing	End date/time of the medication administration represented in ISO 8601 character format.	Perm
CMSTDY	Study Day of Start of Medication	Num		Timing	Study day of start of medication relative to the applicant-defined RFSTDTC.	Perm
CMENDY	Study Day of End of Medication	Num		Timing	Study day of end of medication relative to the applicant-defined RFSTDTC.	Perm
CMDUR	Duration	Char	ISO 8601 duration	Timing	Collected duration for a treatment episode. Used only if collected on the CRF and not derived from start and end date/times.	Perm
CMSTRF	Start Relative to Reference Period	Char	(STENRF)	Timing	Describes the start of the medication relative to applicant-defined reference period. The applicant-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point (represented by RFSTDTC and RFENDTC in Demographics). If information such as "PRIOR" was collected, this information may be translated into CMSTRF.	Perm
CMENRF	End Relative to Reference Period	Char	(STENRF)	Timing	Describes the end of the medication relative to the applicant-defined reference period. The applicant-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point (represented by RFSTDTC and RFENDTC in Demographics). If information such as "PRIOR", "ONGOING, or "CONTINUING" was collected, this information may be translated into CMENRF.	Perm
CMSTRTPT	Start Relative to Reference Time Point	Char	(STENRF)	Timing	Identifies the start of the medication as being before or after the applicant-defined reference time point defined by variable CMSTTPT.	Perm
CMSTTPT	Start Reference Time Point	Char		Timing	Description or date/time in ISO 8601 character format of the applicant-defined reference point referred to by CMSTRTPT. Examples: "2003-12-15", "VISIT 1".	Perm
CMENRTPT	End Relative to Reference Time Point	Char	(STENRF)	Timing	Identifies the end of the medication as being before or after the applicant-defined reference time point defined by variable CMENTPT.	Perm
CMENTPT	End Reference Time Point	Char		Timing	Description or date/time in ISO 8601 character format of the applicant-defined reference point referred to by CMENRTPT. Examples: "2003-12-25", "VISIT 2".	Perm

Assumptions

The structure of the CM domain is 1 record per medication intervention episode, constant-dosing interval, or prespecified medication assessment per subject. It is the applicant's responsibility to define an intervention episode. This definition may vary based on the applicant's requirements for review and analysis. The submission dataset structure may differ from the structure used for collection. One common approach is to submit a new record when there is a change in the dosing regimen. Another approach is to collapse all records for a medication to a summary level with either a dose range or the highest dose level. Other approaches may also be reasonable as long as they meet the applicant's evaluation requirements.
CM description and coding
1. CMTRT is the topic variable and captures the name of the concomitant medication/therapy or the prespecified term used to collect information about the occurrence of any of a group of medications and/or therapies. It is a required variable and must have a value. CMTRT only includes the medication/therapy name and does not include dosage, formulation, or other qualifying information. For example, “ASPIRIN 100MG TABLET” is not a valid value for CMTRT. This example should be expressed as CMTRT= “ASPIRIN”, CMDOSE= “100”, CMDOSU= “MG”, and CMDOSFRM= “TABLET”. When referring to a prespecified group of medications/therapies, CMTRT contains the description of the group used to solicit the occurrence response.
2. CMMODIFY should be included if the applicant’s procedure permits modification of a verbatim term for coding.
3. CMDECOD is the standardized medication/therapy term derived by the applicant from the coding dictionary. It is expected that the reported term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard dictionary. The applicant is expected to provide the dictionary name and version used to map the terms utilizing the external codelist element in the Define-XML document.
4. When CMDECOD values from WHODrug are longer than 200 characters, split the values at semicolons rather than spaces when implementing guidance in Section 2.8.7.1, General Guidance. TOBA-251 - Getting issue details... STATUS
Prespecified terms; presence or absence of concomitant medications
1. Information on concomitant medications is generally collected in 2 different ways, either by recording free text or using a prespecified list of terms. Because the solicitation of information on specific concomitant medications may affect the frequency at which they are reported, the fact that a specific medication was solicited may be of interest to reviewers. CMPRESP and CMOCCUR are used together to indicate whether the intervention in CMTRT was prespecified and whether it occurred, respectively.
2. CMOCCUR is used to indicate whether a prespecified medication was used. A value of "Y" indicates that the medication was used and "N" indicates that it was not.
3. If a medication was not prespecified, the value of CMOCCUR should be null. CMPRESP and CMOCCUR are permissible fields and may be omitted from the dataset if all medications were collected as free text. Values of CMOCCUR may also be null for prespecified medications if no Y/N response was collected; in such cases, CMSTAT = "NOT DONE", and CMREASND could be used to describe the reason the answer was missing.
Variables for timing relative to a time point
1. CMSTRTPT, CMSTTPT, CMENRTPT, and CMENTPT may be populated as necessary to indicate when a medication was used relative to specified time points. For example, assume a subject uses birth control medication. The subject has used the same medication for many years and continues to do so. The date the subject began using the medication (or at least a partial date) would be stored in CMSTDTC. CMENDTC is null because the end date is unknown/has not yet happened. This fact can be recorded by setting CMENTPT = "2007-04-30" (the date the assessment was made) and CMENRTPT = "ONGOING".
Although any identifier variables, timing variables, or interventions general observation-class qualifiers may be added to the CM domain, the following qualifiers would generally not be used: --MOOD, --LOT.

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Adverse Experiences (AE)