Examples SDTM.TE

Example	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
IG33_TE_TE_001	EX1	TE	SCRN	Screen	Informed consent	1 week after start of Element	P7D
IG33_TE_TE_001	EX1	TE	RI	Run-In	Eligibility confirmed	2 weeks after start of Element	P14D
IG33_TE_TE_001	EX1	TE	P	Placebo	First dose of study drug, where drug is placebo	2 weeks after start of Element	P14D
IG33_TE_TE_001	EX1	TE	A	Drug A	First dose of study drug, where drug is Drug A	2 weeks after start of Element	P14D
IG33_TE_TE_001	EX1	TE	B	Drug B	First dose of study drug, where drug is Drug B	2 weeks after start of Element	P14D

Example	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
IG33_TE_TE_002	EX2	TE	SCRN	Screen	Informed consent	2 weeks after start of Element	P14D
IG33_TE_TE_002	EX2	TE	P	Placebo	First dose of a treatment Epoch, where dose is placebo	2 weeks after start of Element	P14D
IG33_TE_TE_002	EX2	TE	5	5 mg	First dose of a treatment Epoch, where dose is 5 mg drug	2 weeks after start of Element	P14D
IG33_TE_TE_002	EX2	TE	10	10 mg	First dose of a treatment Epoch, where dose is 10 mg drug	2 weeks after start of Element	P14D
IG33_TE_TE_002	EX2	TE	REST	Rest	48 hrs after last dose of preceding treatment Epoch	1 week after start of Element	P7D
IG33_TE_TE_002	EX2	TE	FU	Follow-up	48 hrs after last dose of third treatment Epoch	3 weeks after start of Element	P21D

Example	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
IG33_TE_TE_003	EX4	TE	SCRN	Screen	Informed Consent	Screening assessments are complete, up to 2 weeks after start of Element
IG33_TE_TE_003	EX4	TE	A	Trt A	First dose of treatment Element, where drug is Treatment A	5 days after start of Element	P5D
IG33_TE_TE_003	EX4	TE	B	Trt B	First dose of treatment Element, where drug is Treatment B	5 days after start of Element	P5D
IG33_TE_TE_003	EX4	TE	REST	Rest	Last dose of previous treatment cycle + 24 hrs	At least 16 days after start of Element and WBC recovered
IG33_TE_TE_003	EX4	TE	FU	Follow-up	Decision not to treat further	4 weeks	P28D