Examples SDTM.DS

Example	STUDYID	DOMAIN	USUBJID	AESEQ	AETERM	AESTDTC	AEENDTC	AEDECOD	AESOC	AESEV	AESER	AEACN	AEREL	AEOUT	AESCAN	AESCONG	AESDISAB	AESDTH	AESHOSP	AESLIFE	AESOD	AESMIE
IG33_DS_AE_004	ABC123	AE	123102	1	Heart Failure	2003-09-29	2003-09-29	HEART FAILURE	CARDIOVASCULAR SYSTEM	SEVERE	Y	NOT APPLICABLE	DEFINITELY NOT RELATED	FATAL	N	N	N	Y	N	N	N	N

Example	STUDYID	DOMAIN	USUBJID	SUBJID	RFXSTDTC	RFXENDTC	RFICDTC	RFPENDTC	SITEID	INVNAM	ARMCD	ARM	ACTARMCD	ACTARM	ARMNRS	ACTARMUD
IG33_DS_DM_010	XYZ	DM	XYZ-767-001	001	2016-02-14	2016-04-19	2016-02-02	2016-04-24	01	ADAMS, M	DG1INDG	Drug-1+Investigation-Drug	DG1INDG	Drug-1+Investigation-Drug
IG33_DS_DM_010	XYZ	DM	XYZ-767-002	002	2016-02-21	2016-04-24	2016-02-04	2016-04-29	01	ADAMS, M	DG2INDG	Drug-2+Investigation-Drug	DG2INDG	Drug-2+Investigation-Drug

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	EPOCH	DSDTC	DSSTDTC
IG33_DS_DS_001	ABC123	DS	123101	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-21	2003-09-21
IG33_DS_DS_001	ABC123	DS	123101	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-09-30	2003-09-30
IG33_DS_DS_001	ABC123	DS	123101	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-09-30	2003-09-29
IG33_DS_DS_001	ABC123	DS	123101	4	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	TREATMENT	2003-10-31	2003-10-31
IG33_DS_DS_001	ABC123	DS	123101	5	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2003-11-15	2003-11-15
IG33_DS_DS_001	ABC123	DS	123102	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-11-21	2003-11-21
IG33_DS_DS_001	ABC123	DS	123102	2	SUBJECT DENIED MRI PROCEDURE	PROTOCOL VIOLATION	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-11-22	2003-11-20
IG33_DS_DS_001	ABC123	DS	123103	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-15	2003-09-15
IG33_DS_DS_001	ABC123	DS	123103	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-09-30	2003-09-30
IG33_DS_DS_001	ABC123	DS	123103	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-09-30	2003-09-22
IG33_DS_DS_001	ABC123	DS	123103	4	SUBJECT MOVED	LOST TO FOLLOW-UP	DISPOSITION EVENT	STUDY PARTICIPATION	TREATMENT	2003-10-31	2003-10-31
IG33_DS_DS_001	ABC123	DS	123104	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-15	2003-09-15
IG33_DS_DS_001	ABC123	DS	123104	3	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-09-30	2003-09-30
IG33_DS_DS_001	ABC123	DS	123104	2	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-09-30	2003-09-22
IG33_DS_DS_001	ABC123	DS	123104	4	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	TREATMENT	2003-10-15	2003-10-15
IG33_DS_DS_001	ABC123	DS	123104	5	AUTOMOBILE ACCIDENT	DEATH	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2003-10-31	2003-10-29
IG33_DS_DS_001	ABC123	DS	123105	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-28	2003-09-28
IG33_DS_DS_001	ABC123	DS	123105	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-10-02	2003-10-02
IG33_DS_DS_001	ABC123	DS	123105	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-10-02	2003-10-02
IG33_DS_DS_001	ABC123	DS	123105	4	ANEMIA	ADVERSE EVENT	DISPOSITION EVENT	STUDY PARTICIPATION	TREATMENT	2003-10-17	2003-10-17
IG33_DS_DS_001	ABC123	DS	123105	5	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2003-11-02	2003-11-02

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	EPOCH	DSSTDTC
IG33_DS_DS_002	ABC456	DS	456101	1	COMPLETED	COMPLETED	DISPOSITION EVENT	FOLLOW-UP	2003-09-21
IG33_DS_DS_002	ABC456	DS	456102	1	SUBJECT TAKING STUDY MED ERRATICALLY	PROTOCOL VIOLATION	DISPOSITION EVENT	TREATMENT	2003-09-29
IG33_DS_DS_002	ABC456	DS	456103	1	LOST TO FOLLOW-UP	LOST TO FOLLOW-UP	DISPOSITION EVENT	TREATMENT	2003-10-15

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	EPOCH	DSSTDTC
IG33_DS_DS_003	ABC789	DS	789101	1	COMPLETED	COMPLETED	DISPOSITION EVENT	TREATMENT	2004-09-12
IG33_DS_DS_003	ABC789	DS	789101	2	COMPLETED	COMPLETED	DISPOSITION EVENT	FOLLOW-UP	2004-12-20
IG33_DS_DS_003	ABC789	DS	789102	1	SKIN RASH	ADVERSE EVENT	DISPOSITION EVENT	TREATMENT	2004-09-30
IG33_DS_DS_003	ABC789	DS	789102	2	SUBJECT HAD SEVERE RASH	TREATMENT UNBLINDED	OTHER EVENT	TREATMENT	2004-10-01
IG33_DS_DS_003	ABC789	DS	789102	3	COMPLETED	COMPLETED	DISPOSITION EVENT	FOLLOW-UP	2004-12-28

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	EPOCH	DSDTC	DSSTDTC
IG33_DS_DS_004	ABC123	DS	123102	1	Heart Failure	DEATH	DISPOSITION EVENT	TREATMENT	2003-09-29	2003-09-29

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	DSSTDTC	EPOCH
IG33_DS_DS_005	XXX	DS	XXX-767-001	1	PERSISTENT HIGH-LEVEL POSITIVE CULTURES, PER PROTOCOL, LEVOFLOXACIN REMOVAL RECOMMENDED	PHYSICIAN DECISION	DISPOSITION EVENT	LEVOFLOXACIN	2016-02-15	TREATMENT 1
IG33_DS_DS_005	XXX	DS	XXX-767-001	2	COMPLETED	COMPLETED	DISPOSITION EVENT	ISONIAZID	2016-02-15	TREATMENT 1
IG33_DS_DS_005	XXX	DS	XXX-767-001	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-02-25	TREATMENT 1
IG33_DS_DS_005	XXX	DS	XXX-767-001	4	COMPLETED	COMPLETED	DISPOSITION EVENT	ISONIAZID	2016-03-14	TREATMENT 2
IG33_DS_DS_005	XXX	DS	XXX-767-001	5	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-03-24	TREATMENT 2

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	DSSTDTC	EPOCH
IG33_DS_DS_006	XXX	DS	XXX-767-001	1	PERSISTENT HIGH-LEVEL POSITIVE CULTURES, PER PROTOCOL, LEVOFLOXACIN REMOVAL RECOMMENDED	PHYSICIAN DECISION	DISPOSITION EVENT	LEVOFLOXACIN	2016-02-15	TREATMENT 1
IG33_DS_DS_006	XXX	DS	XXX-767-001	2	COMPLETED	COMPLETED	DISPOSITION EVENT	ISONIAZID	2016-03-14	TREATMENT 2
IG33_DS_DS_006	XXX	DS	XXX-767-001	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-03-24	TREATMENT 2

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	DSSTDTC	EPOCH
IG33_DS_DS_007	XXX	DS	XXX-767-001	1	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY TREATMENT	2016-02-15	TREATMENT 1
IG33_DS_DS_007	XXX	DS	XXX-767-001	2	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-02-15	TREATMENT 1
IG33_DS_DS_007	XXX	DS	XXX-767-001	3	SKIN RASH	ADVERSE EVENT	DISPOSITION EVENT	STUDY TREATMENT	2016-03-14	TREATMENT 2
IG33_DS_DS_007	XXX	DS	XXX-767-001	4	SKIN RASH	ADVERSE EVENT	DISPOSITION EVENT	STUDY PARTICIPATION	2016-03-14	TREATMENT 2

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	DSSTDTC	EPOCH
IG33_DS_DS_008	XXX	DS	XXX-767-001	1	COMPLETED	COMPLETED	DISPOSITION EVENT	BLINDED DRUG A	2016-02-15	TREATMENT 1
IG33_DS_DS_008	XXX	DS	XXX-767-001	2	COMPLETED	COMPLETED	DISPOSITION EVENT	BLINDED DRUG B	2016-02-15	TREATMENT 1
IG33_DS_DS_008	XXX	DS	XXX-767-001	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-02-25	TREATMENT 1
IG33_DS_DS_008	XXX	DS	XXX-767-001	4	COMPLETED	COMPLETED	DISPOSITION EVENT	BLINDED DRUG A	2016-03-14	TREATMENT 2
IG33_DS_DS_008	XXX	DS	XXX-767-001	5	COMPLETED	COMPLETED	DISPOSITION EVENT	BLINDED DRUG B	2016-03-14	TREATMENT 2
IG33_DS_DS_008	XXX	DS	XXX-767-001	6	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-03-24	TREATMENT 2

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	EPOCH	DSSTDTC
IG33_DS_DS_009	XXX	DS	XXX-767-001	1	INFORMED CONSENT FOR STUDY ENROLLMENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE	SCREENING	2016-02-22
IG33_DS_DS_009	XXX	DS	XXX-767-001	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE	SCREENING	2016-02-26
IG33_DS_DS_009	XXX	DS	XXX-767-001	3	INFORMED CONSENT FOR AMENDMENT ONE OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE	TREATMENT 1	2016-04-12
IG33_DS_DS_009	XXX	DS	XXX-767-001	4	INFORMED CONSENT FOR PHARMACOGENETIC RESEARCH OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE	TREATMENT 2	2016-06-08
IG33_DS_DS_009	XXX	DS	XXX-767-001	5	INFORMED CONSENT FOR PK SUB-STUDY OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE	TREATMENT 2	2016-06-23

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	DSSTDTC	EPOCH
IG33_DS_DS_010	XYZ	DS	XYZ-767-001	1	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		2016-02-13	SCREENING
IG33_DS_DS_010	XYZ	DS	XYZ-767-001	2	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-02-13	SCREENING
IG33_DS_DS_010	XYZ	DS	XYZ-767-001	3	COMPLETED	COMPLETED	DISPOSITION EVENT	DRUG1	2016-03-13	TREATMENT 1
IG33_DS_DS_010	XYZ	DS	XYZ-767-001	4	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-03-14	TREATMENT 1
IG33_DS_DS_010	XYZ	DS	XYZ-767-001	5	COMPLETED	COMPLETED	DISPOSITION EVENT	DG1INDG	2016-04-19	TREATMENT 2
IG33_DS_DS_010	XYZ	DS	XYZ-767-001	6	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-04-20	TREATMENT 2
IG33_DS_DS_010	XYZ	DS	XYZ-767-001	7	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-04-24	FOLLOW-UP
IG33_DS_DS_010	XYZ	DS	XYZ-767-002	1	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		2016-02-20	SCREENING
IG33_DS_DS_010	XYZ	DS	XYZ-767-002	2	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-02-20	SCREENING
IG33_DS_DS_010	XYZ	DS	XYZ-767-002	3	COMPLETED	COMPLETED	DISPOSITION EVENT	DRUG2	2016-03-23	TREATMENT 1
IG33_DS_DS_010	XYZ	DS	XYZ-767-002	4	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-03-24	TREATMENT 1
IG33_DS_DS_010	XYZ	DS	XYZ-767-002	5	COMPLETED	COMPLETED	DISPOSITION EVENT	DG2INDG	2016-04-24	TREATMENT 2
IG33_DS_DS_010	XYZ	DS	XYZ-767-002	6	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-04-25	TREATMENT 2
IG33_DS_DS_010	XYZ	DS	XYZ-767-002	7	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2016-04-29	FOLLOW-UP

Example	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	DSSTDTC	TAETORD	EPOCH
IG33_DS_DS_011	DS10	DS	101	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		2015-01-21	1	SCREENING
IG33_DS_DS_011	DS10	DS	101	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		2015-02-01	1	SCREENING
IG33_DS_DS_011	DS10	DS	101	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	2015-02-01	1	SCREENING
IG33_DS_DS_011	DS10	DS	101	4	Toxicity	ADVERSE EVENT	DISPOSITION EVENT	DRUG C	2015-03-06	2	TREATMENT
IG33_DS_DS_011	DS10	DS	101	5	Disease progression	PROGRESSIVE DISEASE	DISPOSITION EVENT	DRUGS A & B	2015-04-14	6	TREATMENT
IG33_DS_DS_011	DS10	DS	101	6	Disease progression	PROGRESSIVE DISEASE	DISPOSITION EVENT	STUDY PARTICIPATION	2015-04-26	6	TREATMENT
IG33_DS_DS_011	DS10	DS	101	7	Death due to cancer	DEATH	DISPOSITION EVENT	STUDY PARTICIPATION	2015-09-19	8	FOLLOW-UP

Example	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXDOSE	EXDOSU	EPOCH	EXSTDTC	EXENDTC
IG33_DS_EX_010	XYZ	EX	XYZ-767-001	1	Drug 1	500	mg	TREATMENT 1	2016-02-14	2016-03-13
IG33_DS_EX_010	XYZ	EX	XYZ-767-001	2	Drug 1	500	mg	TREATMENT 2	2016-03-14	2016-04-19
IG33_DS_EX_010	XYZ	EX	XYZ-767-001	3	Investigational Drug	1000	mg	TREATMENT 2	2016-03-14	2016-04-19
IG33_DS_EX_010	XYZ	EX	XYZ-767-002	1	Drug 2	500	mg	TREATMENT 1	2016-02-21	2016-03-23
IG33_DS_EX_010	XYZ	EX	XYZ-767-002	2	Drug 2	500	mg	TREATMENT 2	2016-03-24	2016-04-24
IG33_DS_EX_010	XYZ	EX	XYZ-767-002	3	Investigational Drug	1000	mg	TREATMENT 2	2016-03-24	2016-04-24

Example	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
IG33_DS_RELREC_004	ABC123	DS	123102	DSSEQ	1		1
IG33_DS_RELREC_004	ABC123	AE	123102	AESEQ	1		1

Example	STUDYID	DOMAIN	USUBJID	SESEQ	ETCD	ELEMENT	SESTDTC	SEENDTC	TAETORD	EPOCH
IG33_DS_SE_010	XYZ	SE	XYZ-767-001	1	SCREEN	Screen	2016-02-02	2016-02-14	1	SCREENING
IG33_DS_SE_010	XYZ	SE	XYZ-767-001	2	DRUG1	Drug-1	2016-02-14	2016-03-14	2	TREATMENT 1
IG33_DS_SE_010	XYZ	SE	XYZ-767-001	3	DG1INDG	Drug 1 + Investigational Drug	2016-03-14	2016-04-24	3	TREATMENT 2
IG33_DS_SE_010	XYZ	SE	XYZ-767-001	4	FU	Follow-up	2016-04-24	2016-04-24	4	FOLLOW-UP
IG33_DS_SE_010	XYZ	SE	XYZ-767-002	1	SCREEN	Screen	2016-02-04	2016-02-21	1	SCREENING
IG33_DS_SE_010	XYZ	SE	XYZ-767-002	2	DRUG2	Drug-2	2016-02-21	2016-03-24	2	TREATMENT 1
IG33_DS_SE_010	XYZ	SE	XYZ-767-002	3	DG2INDG	Drug 2 + Investigational Drug	2016-03-24	2016-04-29	3	TREATMENT 2
IG33_DS_SE_010	XYZ	SE	XYZ-767-002	4	FU	Follow-up	2016-04-29	2016-04-29	4	FOLLOW-UP

Example	STUDYID	DOMAIN	USUBJID	SESEQ	ETCD	SESTDTC	SEENDTC	TAETORD	EPOCH
IG33_DS_SE_011	DS10	SE	101	1	SCRN	2015-01-21	2015-02-01	0	SCREENING
IG33_DS_SE_011	DS10	SE	101	2	ABC	2015-02-01	2015-03-01	1	TREATMENT
IG33_DS_SE_011	DS10	SE	101	3	ABC	2015-03-01	2015-03-29	2	TREATMENT
IG33_DS_SE_011	DS10	SE	101	4	AB	2015-03-29	2015-04-26	6	TREATMENT
IG33_DS_SE_011	DS10	SE	101	5	FU	2015-04-26	2015-09-19	8	FOLLOW-UP

Example	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	EPOCH
IG33_DS_TA_010	XYZ	TA	DG1INDG	Drug-1+Investigation-Drug	1	SCRN	Screen	Randomized to DG1INDG	SCREENING
IG33_DS_TA_010	XYZ	TA	DG1INDG	Drug-1+Investigation-Drug	2	DRUG1	Drug-1		TREATMENT 1
IG33_DS_TA_010	XYZ	TA	DG1INDG	Drug-1+Investigation-Drug	3	DG1INDG	Drug 1 + Investigation Drug		TREATMENT 2
IG33_DS_TA_010	XYZ	TA	DG1INDG	Drug-1+Investigation-Drug	4	FU	Follow-up		FOLLOW-UP
IG33_DS_TA_010	XYZ	TA	DG2INDG	Drug-2+Investigation-Drug	1	SCRN	Screen	Randomized to DG2INDG	SCREENING
IG33_DS_TA_010	XYZ	TA	DG2INDG	Drug-2+Investigation-Drug	2	DRUG2	Drug-2		TREATMENT 1
IG33_DS_TA_010	XYZ	TA	DG2INDG	Drug-2+Investigation-Drug	3	DG2INDG	Drug 2 + Investigation Drug		TREATMENT 2
IG33_DS_TA_010	XYZ	TA	DG2INDG	Drug-2+Investigation-Drug	4	FU	Follow-up		FOLLOW-UP

Example	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	TATRANS	EPOCH
IG33_DS_TA_011	DS10	TA	AB	AB	0	SCRN	Screen	Randomized to AB		SCREENING
IG33_DS_TA_011	DS10	TA	AB	AB	1	AB	Trt AB		If disease progression, go to follow-up epoch.	TREATMENT
IG33_DS_TA_011	DS10	TA	AB	AB	2	AB	Trt AB		If disease progression, go to follow-up epoch.	TREATMENT
IG33_DS_TA_011	DS10	TA	AB	AB	3	AB	Trt AB		If disease progression, go to follow-up epoch.	TREATMENT
IG33_DS_TA_011	DS10	TA	AB	AB	4	AB	Trt AB			TREATMENT
IG33_DS_TA_011	DS10	TA	AB	AB	5	FU	Follow-up			FOLLOW-UP
IG33_DS_TA_011	DS10	TA	ABC	ABC	0	SCRN	Screen	Randomized to ABC		SCREENING
IG33_DS_TA_011	DS10	TA	ABC	ABC	1	ABC	Trt ABC		If disease progression, go to follow-up epoch. If drug C is dropped, go to element with TAETORD = "5".	TREATMENT
IG33_DS_TA_011	DS10	TA	ABC	ABC	2	ABC	Trt ABC		If disease progression, go to follow-up epoch. If drug C is dropped, go to element with TAETORD = "6".	TREATMENT
IG33_DS_TA_011	DS10	TA	ABC	ABC	3	ABC	Trt ABC		If disease progression, go to follow-up epoch. If drug C is dropped, go to element with TAETORD = "7".	TREATMENT
IG33_DS_TA_011	DS10	TA	ABC	ABC	4	ABC	Trt ABC		Go to follow-up epoch.	TREATMENT
IG33_DS_TA_011	DS10	TA	ABC	ABC	5	AB	Trt AB			TREATMENT
IG33_DS_TA_011	DS10	TA	ABC	ABC	6	AB	Trt AB			TREATMENT
IG33_DS_TA_011	DS10	TA	ABC	ABC	7	AB	Trt AB			TREATMENT
IG33_DS_TA_011	DS10	TA	ABC	ABC	8	FU	Follow-up			FOLLOW-UP

Example	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
IG33_DS_TE_010	XYZ	TE	SCRN	Screen	Informed Consent	1 week after start of Element	P7D
IG33_DS_TE_010	XYZ	TE	DRUG1	Drug 1	First dose of Drug 1	4 weeks after start of Element	P28D
IG33_DS_TE_010	XYZ	TE	DRUG2	Drug 2	First dose of Drug 2	4 weeks after start of Element	P28D
IG33_DS_TE_010	XYZ	TE	DG1INDG	Drug 1 + Investigation Drug	First dose of Investigational Drug, where Investigational Drug is given with Drug 1.	1 week after start of Element	P7D
IG33_DS_TE_010	XYZ	TE	DG2INDG	Drug 2 + Investigation Drug	First dose of Investigational Drug, where Investigational Drug is given with Drug 2.	1 week after start of Element	P7D
IG33_DS_TE_010	XYZ	TE	FU	Follow-up	One day after last administration of study drug.

Example	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
IG33_DS_TE_011	DS10	TE	SCRN	Screen	Informed Consent	Screening assessments are complete, up to 2 weeks after start of Element
IG33_DS_TE_011	DS10	TE	AB	Trt AB	First dose of treatment Element, where treatment is AB	4 weeks after start of Element	P4W
IG33_DS_TE_011	DS10	TE	ABC	Trt ABC	First dose of treatment Element, where treatment AB +C	4 weeks after start of Element	P4W
IG33_DS_TE_011	DS10	TE	FU	Follow-up	Four weeks after start of last treatment element	Death, withdrawal of consent, or loss to follow-up.