ADaM Example.ADEX EX/EC -New

This is an example of an ADCM dataset and is based primarily on input from the SDTM EX dataset. Other adminstrative data about the subjects are based on the ADSL datset provided ... > add the link.

This is an example of the input SDTM EX dataset used to create the ADEX. Only variables needed for illustration are shown in the example.

ex.xpt

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	SPTOBID	EXREFID	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXROUTE	EXPSTRG	EXPSTRGU	EXSTDTC	EXENDTC
1	A123	EX	A2001	1	VAPE-Z27	CRT8754	e-nicotine liquid	6	mL	CARTRIDGE	RESPIRATORY (INHALATION)	0	mg/mL	2021-01-08	2020-01-14
2	A123	EX	A2001	2	VAPE-Z27	CRT8768	e-nicotine liquid	6.4	mL	CARTRIDGE	RESPIRATORY (INHALATION)	0	mg/mL	2021-01-15	2020-01-21
3	A123	EX	A2001	3	VAPE-Z27	CRT9756	e-nicotine liquid	7	mL	CARTRIDGE	RESPIRATORY (INHALATION)	0	mg/mL	2021-01-22	2020-01-28
4	A123	EX	A2008	1	VAPE-Z27	CRT8000	e-nicotine liquid	5	mL	CARTRIDGE	RESPIRATORY (INHALATION)	8	mg/mL	20221-02-08	2021-02-14
5	A123	EX	A2008	2	VAPE-Z27	CRT9006	e-nicotine liquid	7	mL	CARTRIDGE	RESPIRATORY (INHALATION)	8	mg/mL	20221-02-15	2021-02-21
6	A123	EX	A2008	3	VAPE-Z27	CRT9008	e-nicotine liquid	8	mL	CARTRIDGE	RESPIRATORY (INHALATION)	8	mg/mL	20221-02-22	2021-03-01
7	A123	EX	A3009	1	VAPE-Z27	CRT9128	e-nicotine liquid	8	mL	CARTRIDGE	RESPIRATORY (INHALATION)	4	mg/mL	2021-06-09	2021-06-15
8	A123	EX	A3009	2	VAPE-Z27	CRT6868	e-nicotine liquid	6.7	mL	CARTRIDGE	RESPIRATORY (INHALATION)	4	mg/mL	2021-06-16	2020-10-15
9	TENDS01	EX	A3009	3	VAPE-Z27	CRT7868	e-nicotine liquid	5.5	mL	CARTRIDGE	RESPIRATORY (INHALATION)	4	mg/mL	2020-10-15	2020-10-22

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This is an example of the ADEX dataset and associated metadata.

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adex.xpt

STUDYID	USUBJID	EXSTDTC	EXENDTC	TRTP	EXTRT	EXDOSE	EXDOSU	SAFFL	EXSEQ
TENDS01	TEN01001	2020-06-26	2020-07-01	Product A	e-nicotine liquid	6	mL	Y	1
TENDS01	TEN01001	2020-07-01	2020-07-06	Product A	e-nicotine liquid	6.4	mL	Y	2
TENDS01	TEN01001	2020-07-06	2020-07-10	Product A	e-nicotine liquid	7	mL	Y	3
TENDS01	TEN01001	2020-07-10	2020-07-14	Product A	e-nicotine liquid	8	mL	Y	4
TENDS01	TEN10002	2020-09-01	2020-09-07	Product B	e-nicotine liquid	5	mL	Y	1
TENDS01	TEN10002	2020-09-07	2020-09-14	Product B	e-nicotine liquid	7	mL	Y	2
TENDS01	TEN10002	2020-09-14	2020-09-21	Product B	e-nicotine liquid	8	mL	Y	3
TENDS01	TEN10002	2020-09-21	2020-09-28	Product B	e-nicotine liquid	6	mL	Y	4
TENDS01	TEN10002	2020-09-28	2020-09-31	Product B	e-nicotine liquid	7	mL	Y	5
TENDS01	TEN10002	2020-10-31	2020-10-08	Product B	e-nicotine liquid	8	mL	Y	6
TENDS01	TEN10002	2020-10-08	2020-10-15	Product B	e-nicotine liquid	6.7	mL	Y	7
TENDS01	TEN10002	2020-10-15	2020-10-22	Product B	e-nicotine liquid	5.5	mL	Y	8

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ADEX Dataset Metadata

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADEX		SET	One record per subject	Analysis		ADEX.xpt	ADEX.SAS/SAP

ADEX Variable Metadata

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Core	Notes
STUDYID	Study Identifier	Char		Req	DM.STUDYID
USUBJID	Unique Subject Identifier	Char		Req	DM.USUBJID
SUBJID	Subject Identifier for the Study	Char		Req	DM.SUBJID
SITEID	Study Site Identifier	Char		Req	DM.SITEID
AGE	Age	Num		Req	DM.AGE. If analysis needs require a derived age that does not match DM.AGE, then AAGE must be added
AGEU	Age Units	Char	(AGEU)	Req	DM.AGEU
AGEGRy	Pooled Age Group y	Char		Perm	Character description of a grouping or pooling of the subject's age for analysis purposes. For example, AGEGR1 might have values of "<18", "18-65", and ">65"; AGEGR2 might have values of "Less than 35 y old" and "At least 35 y old".
SEX	Sex	Char	SEX)	Req	DM.SEX
RACE	Race	Char	(RACE)	Req	DM.RACE
RACEGRy	Pooled Race Group y	Char		Perm	Character description of a grouping or pooling of the subject's race for analysis purposes.
ETHNIC	Ethnicity	Char		Perm	DM.ETHNIC
SAFFL	Safety Population Flag	Char	Y; N	Cond	Y if ADSL.TR01SDT is not null, otherwise N
PPROTFL	Per-Protocol Population Flag	Char	Y; N	Cond	Y if ADSL.SAFFL=Y and at least one post-baseline assessment was done, otherwise N
RANDFL	Randomized Population Flag	Char	Y; N	Cond	Y if the subject was randomized, otherwise N
ARM	Description of Planned Arm	Char		Req	DM.ARM
ACTARM	Description of Actual Arm	Char		Perm	DM.ACTARM
TRTxxP	Planned Treatment for Period xx	Char		Req	Subject-level identifier that represents the planned treatment for period xx. In a one-period randomized trial, TRT01P would be the treatment to which the subject was randomized. TRTxxP might be derived from the SDTM DM variable ARM. At least TRT01P is required.
TRTxxPN	Planned Treatment for Period xx (N)	Num		Perm	Numeric representation of TRTxxP. There must be a one-to-one relationship between TRTxxPN and TRTxxP within a study. TRTxxPN cannot be present unless TRTxxP is also present. When TRTxxP and TRTxxPN are present, then on a given record, either both must be populated or both must be null.
TRTxxA	Actual Treatment for Period xx	Char		Cond	Subject-level identifier that represents the actual treatment for the subject for period xx. Required when actual treatment does not match planned and there is an analysis of the data as treated.
TRTxxAN	Actual Treatment for Period xx (N)	Num		Perm	Numeric representation of TRTxxA. There must be a one-to-one relationship between TRTxxAN and TRTxxA within a study. TRTxxAN cannot be present unless TRTxxA is also present. When TRTxxA and TRTxxAN are present, then on a given record, either both must be populated or both must be null.
TRTSEQP		Char		Cond	Required when there is an analysis based on the sequence of treatments, for example in a crossover design. TRTSEQP is not necessarily equal to ARM, for example if ARM contains elements that are not relevant to analysis of treatments or ARM is not fully descriptive (e.g., "GROUP 1," "GROUP 2"). When analyzing based on the sequence of treatments, TRTSEQP is required even if identical to ARM.
TRTSDT	Date of First Exposure to Treatment	Num		Cond	Date of first exposure to treatment for a subject in a study. TRTSDT and/or TRTSDTM are required if there is an investigational product. Note that TRTSDT is not required to have the same value as the SDTM DM variable RFXSTDTC. While both of these dates reflect the concept of first exposure, the ADaM date may be derived to support the analysis which may not necessarily be the very first date in the SDTM EX domain.
TRTSDTM	Datetime of First Exposure to Treatment	Num		Cond	Datetime of first exposure to treatment for a subject in a study. TRTSDT and/or TRTSDTM are required if there is an investigational product.
TRTEDT	Date of Last Exposure to Treatment	Num		Cond	Date of last exposure to treatment for a subject in a study. TRTEDT and/or TRTEDTM are required if there is an investigational product. Note that TRTEDT is not required to have the same value as the SDTM DM variable RFXENDTC. While both of these dates reflect the concept of last exposure, the ADaM date may be derived to support the analysis which may not necessarily be the very last date in the SDTM EX domain.
TRTEDTM	Datetime of Last Exposure to Treatment	Num		Cond	Datetime of last exposure to treatment for a subject in a study. TRTEDT and/or TRTEDTM are required if there is an investigational product.
TRxxSDT	Date of First Exposure in Period xx	Num		Cond	Date of first exposure to treatment in period xx. TRxxSDT and/or TRxxSDTM are only required in trial designs where multiple treatment periods are defined (i.e., required when there is a TRTxxP other than TRT01P). Examples include crossover designs or designs where multiple periods exist for the same treatment.
TRxxEDT	Date of Last Exposure in Period xx	Num		Cond	Date of last exposure to treatment in period xx. TRxxEDT and/or TRxxEDTM are only required in trial designs where multiple treatment periods are defined (i.e., required when there is a TRTxxP other than TRT01P).
APHASEw	Description of Phase w	Char		Perm	Description of analysis phase w. Analysis phase is independent of TRTxxP within ADSL, and may be populated for spans of time where a subject is not on treatment.
EOSSTT	End of Study Status	Char	(SBJTSTAT)	Perm	The subject's status as of the end of study or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING.
EOSDT	End of Study Date	Num		Perm	Date subject ended the study - either date of completion or date of discontinuation or data cutoff date for interim analyses.
DCSREAS	Reason for Discontinuation from Study	Char		Perm	Reason for subject's discontinuation from study. The source would most likely be the SDTM DS dataset. Null for subjects who completed the study.
DCSREASP	DCSREASP Reason Spec for Discont from Study	Char		Perm	Additional detail regarding subject's discontinuation from study (e.g., description of "other").
EOTSTT	End of Treatment Status	Char	(SBJTSTAT)	Perm	The subject's status as of the end of treatment or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING.
DCTREAS	Reason for Discontinuation of Treatment	Char		Perm	If a subject discontinued treatment in the study, then this variable indicates the reason for discontinuation. This is for discontinuation of treatment in the overall study and not to be used for discontinuation reason within individual treatment periods.
DCTREASP	Reason Specify for Discont of Treatment	Char		Perm	Additional detail regarding subject's discontinuation from treatment (e.g., description of "other").
RFICDT	Date of Informed Consent	Num		Perm	Date subject gave informed consent. Generally equivalent to DM.RFICDTC.
ENRLDT	Date of Enrollment	Num		Perm	Date of subject's enrollment into trial.
RANDDT	Date of Randomization	Num		Cond	Required in randomized trials.
LSTALVDT	Date Last Known Alive	Num		Perm	If this variable is included in ADSL, the best practice is to populate it for everyone. If the derivation for subjects who died differs from the derivation for subjects who are not known to have died, the differences should be noted in metadata.
TRTDURD	Total Treatment Duration (Days)	Num		Perm	Total treatment duration, as measured in days. More than one of TRTDURD, TRTDURM, and TRTDURY can be populated, but each represents the entire duration in its respective units.
DTHDT	Date of Death	Num		Perm	Date of subject's death. Derived from DM.DTHDTC.
DTHCAUS	Cause of Death	Char		Perm	Cause of Death.
STRATAR	Strata Used for Randomization	Char		Perm	STRATAR contains the combination of values of the individual stratification factors used for randomization. The exact format should be determined by the sponsor. This variable is intended for studies that use stratified randomization. For example, ">=50, Treatment experienced, N"
STRATAV	Strata from Verification Source	Char		Perm	STRATAV contains the entire string value represents the combination of values of the individual stratification factors that should have been used and represents the "as verified" value. The STRATAV variables are based on the source documentation and are determined after randomization. If the values used for the randomization of a given subject were all correct, then STRATAV will equal STRATAR. Otherwise, one or more components of the text string for STRATAR and STRATAV will be different. The exact format should be determined by the sponsor. For example, ">=50, Treatment experienced, Y"

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ADaM Example.ADEX EX/EC -New