Examples SDTM.TA

Example	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	EPOCH
IG33_TA_TA_001	EX1	TA	P	Placebo	1	SCRN	Screen		SCREENING
IG33_TA_TA_001	EX1	TA	P	Placebo	2	RI	Run-In	Randomized to Placebo	RUN-IN
IG33_TA_TA_001	EX1	TA	P	Placebo	3	P	Placebo		TREATMENT
IG33_TA_TA_001	EX1	TA	A	A	1	SCRN	Screen		SCREENING
IG33_TA_TA_001	EX1	TA	A	A	2	RI	Run-In	Randomized to Drug A	RUN-IN
IG33_TA_TA_001	EX1	TA	A	A	3	A	Drug A		TREATMENT
IG33_TA_TA_001	EX1	TA	B	B	1	SCRN	Screen		SCREENING
IG33_TA_TA_001	EX1	TA	B	B	2	RI	Run-In	Randomized to Drug B	RUN-IN
IG33_TA_TA_001	EX1	TA	B	B	3	B	Drug B		TREATMENT

Example	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	EPOCH
IG33_TA_TA_002	EX2	TA	P-5-10	Placebo-5mg-10mg	1	SCRN	Screen	Randomized to Placebo - 5 mg - 10 mg	SCREENING
IG33_TA_TA_002	EX2	TA	P-5-10	Placebo-5mg-10mg	2	P	Placebo		TREATMENT 1
IG33_TA_TA_002	EX2	TA	P-5-10	Placebo-5mg-10mg	3	REST	Rest		WASHOUT 1
IG33_TA_TA_002	EX2	TA	P-5-10	Placebo-5mg-10mg	4	5	5 mg		TREATMENT 2
IG33_TA_TA_002	EX2	TA	P-5-10	Placebo-5mg-10mg	5	REST	Rest		WASHOUT 2
IG33_TA_TA_002	EX2	TA	P-5-10	Placebo-5mg-10mg	6	10	10 mg		TREATMENT 3
IG33_TA_TA_002	EX2	TA	P-5-10	Placebo-5mg-10mg	7	FU	Follow-up		FOLLOW-UP
IG33_TA_TA_002	EX2	TA	5-P-10	5mg-Placebo-10mg	1	SCRN	Screen	Randomized to 5 mg - Placebo - 10 mg	SCREENING
IG33_TA_TA_002	EX2	TA	5-P-10	5mg-Placebo-10mg	2	5	5 mg		TREATMENT 1
IG33_TA_TA_002	EX2	TA	5-P-10	5mg-Placebo-10mg	3	REST	Rest		WASHOUT 1
IG33_TA_TA_002	EX2	TA	5-P-10	5mg-Placebo-10mg	4	P	Placebo		TREATMENT 2
IG33_TA_TA_002	EX2	TA	5-P-10	5mg-Placebo-10mg	5	REST	Rest		WASHOUT 2
IG33_TA_TA_002	EX2	TA	5-P-10	5mg-Placebo-10mg	6	10	10 mg		TREATMENT 3
IG33_TA_TA_002	EX2	TA	5-P-10	5mg-Placebo-10mg	7	FU	Follow-up		FOLLOW-UP
IG33_TA_TA_002	EX2	TA	5-10-P	5mg-10mg-Placebo	1	SCRN	Screen	Randomized to 5 mg - 10 mg – Placebo	SCREENING
IG33_TA_TA_002	EX2	TA	5-10-P	5mg-10mg-Placebo	2	5	5 mg		TREATMENT 1
IG33_TA_TA_002	EX2	TA	5-10-P	5mg-10mg-Placebo	3	REST	Rest		WASHOUT 1
IG33_TA_TA_002	EX2	TA	5-10-P	5mg-10mg-Placebo	4	10	10 mg		TREATMENT 2
IG33_TA_TA_002	EX2	TA	5-10-P	5mg-10mg-Placebo	5	REST	Rest		WASHOUT 2
IG33_TA_TA_002	EX2	TA	5-10-P	5mg-10mg-Placebo	6	P	Placebo		TREATMENT 3
IG33_TA_TA_002	EX2	TA	5-10-P	5mg-10mg-Placebo	7	FU	Follow-up		FOLLOW-UP

Example	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	EPOCH
IG33_TA_TA_003	EX3	TA	AA	A-Open A	1	SCRN	Screen	Randomized to Treatment A	SCREENING
IG33_TA_TA_003	EX3	TA	AA	A-Open A	2	DBA	Treatment A	Assigned to Open Drug A on basis of response evaluation	BLINDED TREATMENT
IG33_TA_TA_003	EX3	TA	AA	A-Open A	3	OA	Open Drug A		OPEN LABEL TREATMENT
IG33_TA_TA_003	EX3	TA	AR	A-Rescue	1	SCRN	Screen	Randomized to Treatment A	SCREENING
IG33_TA_TA_003	EX3	TA	AR	A-Rescue	2	DBA	Treatment A	Assigned to Rescue on basis of response evaluation	BLINDED TREATMENT
IG33_TA_TA_003	EX3	TA	AR	A-Rescue	3	RSC	Rescue		OPEN LABEL TREATMENT
IG33_TA_TA_003	EX3	TA	BA	B-Open A	1	SCRN	Screen	Randomized to Treatment B	SCREENING
IG33_TA_TA_003	EX3	TA	BA	B-Open A	2	DBB	Treatment B	Assigned to Open Drug A on basis of response evaluation	BLINDED TREATMENT
IG33_TA_TA_003	EX3	TA	BA	B-Open A	3	OA	Open Drug A		OPEN LABEL TREATMENT
IG33_TA_TA_003	EX3	TA	BR	B-Rescue	1	SCRN	Screen	Randomized to Treatment B	SCREENING
IG33_TA_TA_003	EX3	TA	BR	B-Rescue	2	DBB	Treatment B	Assigned to Rescue on basis of response evaluation	BLINDED TREATMENT
IG33_TA_TA_003	EX3	TA	BR	B-Rescue	3	RSC	Rescue		OPEN LABEL TREATMENT

Example	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	TATRANS	EPOCH
IG33_TA_TA_004	EX4	TA	A	A	1	SCRN	Screen	Randomized to A		SCREENING
IG33_TA_TA_004	EX4	TA	A	A	2	A	Trt A			TREATMENT
IG33_TA_TA_004	EX4	TA	A	A	3	REST	Rest		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_004	EX4	TA	A	A	4	A	Trt A			TREATMENT
IG33_TA_TA_004	EX4	TA	A	A	5	REST	Rest		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_004	EX4	TA	A	A	6	A	Trt A			TREATMENT
IG33_TA_TA_004	EX4	TA	A	A	7	REST	Rest		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_004	EX4	TA	A	A	8	A	Trt A			TREATMENT
IG33_TA_TA_004	EX4	TA	A	A	9	REST	Rest			TREATMENT
IG33_TA_TA_004	EX4	TA	A	A	10	FU	Follow-up			FOLLOW-UP
IG33_TA_TA_004	EX4	TA	B	B	1	SCRN	Screen	Randomized to B		SCREENING
IG33_TA_TA_004	EX4	TA	B	B	2	B	Trt B			TREATMENT
IG33_TA_TA_004	EX4	TA	B	B	3	REST	Rest		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_004	EX4	TA	B	B	4	B	Trt B			TREATMENT
IG33_TA_TA_004	EX4	TA	B	B	5	REST	Rest		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_004	EX4	TA	B	B	6	B	Trt B			TREATMENT
IG33_TA_TA_004	EX4	TA	B	B	7	REST	Rest		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_004	EX4	TA	B	B	8	B	Trt B			TREATMENT
IG33_TA_TA_004	EX4	TA	B	B	9	REST	Rest			TREATMENT
IG33_TA_TA_004	EX4	TA	B	B	10	FU	Follow-up			FOLLOW-UP

Example	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	TATRANS	EPOCH
IG33_TA_TA_005	EX5	TA	A	A	1	SCRN	Screen	Randomized to A		SCREENING
IG33_TA_TA_005	EX5	TA	A	A	2	A	Trt A			TREATMENT
IG33_TA_TA_005	EX5	TA	A	A	3	RESTA	Rest A		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_005	EX5	TA	A	A	4	A	Trt A			TREATMENT
IG33_TA_TA_005	EX5	TA	A	A	5	RESTA	Rest A		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_005	EX5	TA	A	A	6	A	Trt A			TREATMENT
IG33_TA_TA_005	EX5	TA	A	A	7	RESTA	Rest A			TREATMENT
IG33_TA_TA_005	EX5	TA	A	A	8	FU	Follow-up			FOLLOW-UP
IG33_TA_TA_005	EX5	TA	B	B	1	SCRN	Screen	Randomized to B		SCREENING
IG33_TA_TA_005	EX5	TA	B	B	2	B	Trt B			TREATMENT
IG33_TA_TA_005	EX5	TA	B	B	3	RESTB	Rest B		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_005	EX5	TA	B	B	4	B	Trt B			TREATMENT
IG33_TA_TA_005	EX5	TA	B	B	5	RESTB	Rest B		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_005	EX5	TA	B	B	6	B	Trt B			TREATMENT
IG33_TA_TA_005	EX5	TA	B	B	7	RESTB	Rest B			TREATMENT
IG33_TA_TA_005	EX5	TA	B	B	8	FU	Follow-up			FOLLOW-UP

Example	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	TATRANS	EPOCH
IG33_TA_TA_006	EX6	TA	A	A	1	SCRN	Screen	Randomized to A		SCREENING
IG33_TA_TA_006	EX6	TA	A	A	2	A	Trt A			TREATMENT
IG33_TA_TA_006	EX6	TA	A	A	3	RESTA	Rest A		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_006	EX6	TA	A	A	4	A	Trt A			TREATMENT
IG33_TA_TA_006	EX6	TA	A	A	5	RESTA	Rest A		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_006	EX6	TA	A	A	6	A	Trt A			TREATMENT
IG33_TA_TA_006	EX6	TA	A	A	7	RESTA	Rest A		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_006	EX6	TA	A	A	8	A	Trt A			TREATMENT
IG33_TA_TA_006	EX6	TA	A	A	9	RESTA	Rest A			TREATMENT
IG33_TA_TA_006	EX6	TA	A	A	10	FU	Follow-up			FOLLOW-UP
IG33_TA_TA_006	EX6	TA	B	B	1	SCRN	Screen	Randomized to B		SCREENING
IG33_TA_TA_006	EX6	TA	B	B	2	B	Trt B			TREATMENT
IG33_TA_TA_006	EX6	TA	B	B	3	RESTB	Rest B		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_006	EX6	TA	B	B	4	B	Trt B			TREATMENT
IG33_TA_TA_006	EX6	TA	B	B	5	RESTB	Rest B		If disease progression, go to Follow-up Epoch	TREATMENT
IG33_TA_TA_006	EX6	TA	B	B	6	B	Trt B			TREATMENT
IG33_TA_TA_006	EX6	TA	B	B	7	RESTB	Rest B			TREATMENT
IG33_TA_TA_006	EX6	TA	B	B	8	FU	Follow-up			FOLLOW-UP

Example	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	TATRANS	EPOCH
IG33_TA_TA_007	EX7	TA	1	CR	1	SCRN	Screen	Randomized to CR		SCREENING
IG33_TA_TA_007	EX7	TA	1	CR	2	ICR	Initial Chemo + RT			INDUCTION TREATMENT
IG33_TA_TA_007	EX7	TA	1	CR	3	CRNS	Chemo+RT (non-Surgery)		If progression, skip to Follow-up.	INDUCTION TREATMENT
IG33_TA_TA_007	EX7	TA	1	CR	4	C	Chemo			CONTINUATION TREATMENT
IG33_TA_TA_007	EX7	TA	1	CR	5	C	Chemo			CONTINUATION TREATMENT
IG33_TA_TA_007	EX7	TA	1	CR	6	FU	Off Treatment Follow-up			FOLLOW-UP
IG33_TA_TA_007	EX7	TA	2	CRS	1	SCRN	Screen	Randomized to CRS		SCREENING
IG33_TA_TA_007	EX7	TA	2	CRS	2	ICR	Initial Chemo + RT			INDUCTION TREATMENT
IG33_TA_TA_007	EX7	TA	2	CRS	3	CRS	Chemo+RT (Surgery)		If progression, skip to Follow-up. If no progression, but subject is ineligible for or does not consent to surgery, skip to Chemo.	INDUCTION TREATMENT
IG33_TA_TA_007	EX7	TA	2	CRS	4	R3	3-5 week rest			CONTINUATION TREATMENT
IG33_TA_TA_007	EX7	TA	2	CRS	5	SURG	Surgery			CONTINUATION TREATMENT
IG33_TA_TA_007	EX7	TA	2	CRS	6	R4	4-6 week rest			CONTINUATION TREATMENT
IG33_TA_TA_007	EX7	TA	2	CRS	7	C	Chemo			CONTINUATION TREATMENT
IG33_TA_TA_007	EX7	TA	2	CRS	8	C	Chemo			CONTINUATION TREATMENT
IG33_TA_TA_007	EX7	TA	2	CRS	9	FU	Off Treatment Follow-up			FOLLOW-UP