ADaM Example.ADEX EX/EC Example 1

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adex.xpt

Row	STUDYID	USUBJID	ADT	ADY	EXTRT	DOSCUMA	EXSTDTC	EXENDTC	TRTA	EXDOSE	EXDOSU	SAFFL
1	A123	A2001	8-Jan-21	1	e-nicotine liquid	6	021-01-08	2021-01-14	Placebo	6	mL	Y
2	A123	A2001	9-Jan-21	2	e-nicotine liquid	12	021-01-08	2021-01-14	Placebo	6	mL	Y
3	A123	A2001	10-Jan-21	3	e-nicotine liquid	18	021-01-08	2021-01-14	Placebo	6	mL	Y
4	A123	A2001	11-Jan-21	4	e-nicotine liquid	24	021-01-08	2021-01-14	Placebo	6	mL	Y
5	A123	A2001	12-Jan-21	5	e-nicotine liquid	30	021-01-08	2021-01-14	Placebo	6	mL	Y
6	A123	A2001	13-Jan-21	6	e-nicotine liquid	36	021-01-08	2021-01-14	Placebo	6	mL	Y
7	A123	A2001	14-Jan-21	7	e-nicotine liquid	42	021-01-08	2021-01-14	Placebo	6	mL	Y
8	A123	A2001	15-Jan-21	8	e-nicotine liquid	48.4	2021-01-15	2021-01-21	Placebo	6.4	mL	Y
9	A123	A2001	16-Jan-21	9	e-nicotine liquid	54.8	2021-01-15	2021-01-21	Placebo	6.4	mL	Y
10	A123	A2001	17-Jan-21	10	e-nicotine liquid	61.2	2021-01-15	2021-01-21	Placebo	6.4	mL	Y
11	A123	A2001	18-Jan-21	11	e-nicotine liquid	67.6	2021-01-15	2021-01-21	Placebo	6.4	mL	Y
12	A123	A2001	19-Jan-21	12	e-nicotine liquid	74	2021-01-15	2021-01-21	Placebo	6.4	mL	Y
13	A123	A2001	20-Jan-21	13	e-nicotine liquid	80.4	2021-01-15	2021-01-21	Placebo	6.4	mL	Y
14	A123	A2001	21-Jan-21	14	e-nicotine liquid	86.8	2021-01-15	2021-01-21	Placebo	6.4	mL	Y
15	A123	A2001	22-Jan-21	15	e-nicotine liquid	93.8	2021-01-22	2021-01-28	Placebo	7	mL	Y
16	A123	A2001	23-Jan-21	16	e-nicotine liquid	100.8	2021-01-22	2021-01-28	Placebo	7	mL	Y
17	A123	A2001	24-Jan-21	17	e-nicotine liquid	107.8	2021-01-22	2021-01-28	Placebo	7	mL	Y
18	A123	A2001	25-Jan-21	18	e-nicotine liquid	114.8	2021-01-22	2021-01-28	Placebo	7	mL	Y
19	A123	A2001	26-Jan-21	19	e-nicotine liquid	121.8	2021-01-22	2021-01-28	Placebo	7	mL	Y
20	A123	A2001	27-Jan-21	20	e-nicotine liquid	128.8	2021-01-22	2021-01-28	Placebo	7	mL	Y
21	A123	A2001	28-Jan-21	21	e-nicotine liquid	135.8	2021-01-22	2021-01-28	Placebo	7	mL	Y
22	A123	A2008	8-Feb-21	1	e-nicotine liquid	5	2021-02-08	2021-02-14	Product A	5	mL	Y
23	A123	A2008	9-Feb-21	2	e-nicotine liquid	10	2021-02-08	2021-02-14	Product A	5	mL	Y
24	A123	A2008	10-Feb-21	3	e-nicotine liquid	15	2021-02-08	2021-02-14	Product A	5	mL	Y
25	A123	A2008	11-Feb-21	4	e-nicotine liquid	20	2021-02-08	2021-02-14	Product A	5	mL	Y
26	A123	A2008	12-Feb-21	5	e-nicotine liquid	25	2021-02-08	2021-02-14	Product A	5	mL	Y
27	A123	A2008	13-Feb-21	6	e-nicotine liquid	30	2021-02-08	2021-02-14	Product A	5	mL	Y
28	A123	A2008	14-Feb-21	7	e-nicotine liquid	35	2021-02-08	2021-02-14	Product A	5	mL	Y
29	A123	A2008	15-Feb-21	8	e-nicotine liquid	42	2021-02-15	2021-02-21	Product A	7	mL	Y
30	A123	A2008	16-Feb-21	9	e-nicotine liquid	49	2021-02-15	2021-02-21	Product A	7	mL	Y
31	A123	A2008	17-Feb-21	10	e-nicotine liquid	56	2021-02-15	2021-02-21	Product A	7	mL	Y
32	A123	A2008	18-Feb-21	11	e-nicotine liquid	63	2021-02-15	2021-02-21	Product A	7	mL	Y
33	A123	A2008	19-Feb-21	12	e-nicotine liquid	70	2021-02-15	2021-02-21	Product A	7	mL	Y
34	A123	A2008	20-Feb-21	13	e-nicotine liquid	77	2021-02-15	2021-02-21	Product A	7	mL	Y
35	A123	A2008	21-Feb-21	14	e-nicotine liquid	84	2021-02-15	2021-02-21	Product A	7	mL	Y
36	A123	A2008	22-Feb-21	15	e-nicotine liquid	92	2021-02-22	2021-03-01	Product A	8	mL	Y
37	A123	A2008	23-Feb-21	16	e-nicotine liquid	100	2021-02-22	2021-03-01	Product A	8	mL	Y
38	A123	A2008	24-Feb-21	17	e-nicotine liquid	108	2021-02-22	2021-03-01	Product A	8	mL	Y
39	A123	A2008	25-Feb-21	18	e-nicotine liquid	116	2021-02-22	2021-03-01	Product A	8	mL	Y
40	A123	A2008	26-Feb-21	19	e-nicotine liquid	124	2021-02-22	2021-03-01	Product A	8	mL	Y
41	A123	A2008	27-Feb-21	20	e-nicotine liquid	132	2021-02-22	2021-03-01	Product A	8	mL	Y
42	A123	A2008	28-Feb-21	21	e-nicotine liquid	140	2021-02-22	2021-03-01	Product A	8	mL	Y
43	A123	A2008	1-Mar-21	22	e-nicotine liquid	148	2021-02-22	2021-03-01	Product A	8	mL	Y
44	A123	A3009	9-Jun-21	1	e-nicotine liquid	8	2021-06-09	2021-06-15	Product B	8	mL	Y
45	A123	A3009	10-Jun-21	2	e-nicotine liquid	16	2021-06-09	2021-06-15	Product B	8	mL	Y
46	A123	A3009	11-Jun-21	3	e-nicotine liquid	24	2021-06-09	2021-06-15	Product B	8	mL	Y
47	A123	A3009	12-Jun-21	4	e-nicotine liquid	32	2021-06-09	2021-06-15	Product B	8	mL	Y
48	A123	A3009	13-Jun-21	5	e-nicotine liquid	40	2021-06-09	2021-06-15	Product B	8	mL	Y
49	A123	A3009	14-Jun-21	6	e-nicotine liquid	48	2021-06-09	2021-06-15	Product B	8	mL	Y
50	A123	A3009	15-Jun-21	7	e-nicotine liquid	56	2021-06-09	2021-06-15	Product B	8	mL	Y
51	A123	A3009	16-Jun-21	8	e-nicotine liquid	62.7	2021-06-16	2021-06-21	Product B	6.7	mL	Y
52	A123	A3009	17-Jun-21	9	e-nicotine liquid	69.4	2021-06-16	2021-06-21	Product B	6.7	mL	Y
53	A123	A3009	18-Jun-21	10	e-nicotine liquid	76.1	2021-06-16	2021-06-21	Product B	6.7	mL	Y
54	A123	A3009	19-Jun-21	11	e-nicotine liquid	82.8	2021-06-16	2021-06-21	Product B	6.7	mL	Y
55	A123	A3009	20-Jun-21	12	e-nicotine liquid	89.5	2021-06-16	2021-06-21	Product B	6.7	mL	Y
56	A123	A3009	21-Jun-21	13	e-nicotine liquid	96.2	2021-06-16	2021-06-21	Product B	6.7	mL	Y

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ADXX Variable Metadata

Variable Name	Variable Label	Type	Core	CDISC Notes
STUDYID	Study Identifier	text	Req	EX.STUDYID
USUBJID	Unique Subject Identifier	text	Req	EX.USUBJID
ADT	Analysis Start Date	integer	Perm	create a value for every date from EX.EXSTDTC to EX.EXENDTC
ADY	Analysis Start Relative Day	integer	Perm	ADT.TRTSDT+1
EXTRT	Name of Treatment	text	Req	EX.EXTRT
DOSCUMA	Cumulative Actual Treatment Dose	float	Perm	Cumulative dose within USUBJID
EXSTDTC	Start Date/Time of Treatment	text	Perm	EX.EXSTDTC
EXENDTC	End Date/Time of Treatment	text	Perm	EX.EXENDTC
TRTA	Actual Treatment	text	Cond	ADSL.TRT01A
EXDOSE	Dose	float	Perm	EX.EXDOSE
EXDOSU	Dose Units	text	Perm	EX.EXDOSU
SAFFL	Safety Population Flag	text	Cond	ADSL.SAFFL

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adexsum.xpt

STUDYID	USUBJID	TRTA	PARAM	PARAMCD	PARAMN	AVAL	SAFFL
A123	A2001	Placebo	Number of Doses	NDOSES	1	21	Y
A123	A2001	Placebo	Average Daily Dose	ADD	2	6.466667	Y
A123	A2001	Placebo	Total Dose	TOTDOSE	3	135.8	Y
A123	A2008	Product A	Number of Doses	NDOSES	1	22	Y
A123	A2008	Product A	Average Daily Dose	ADD	2	6.727273	Y
A123	A2008	Product A	Total Dose	TOTDOSE	3	148	Y
A123	A3009	Product B	Number of Doses	NDOSES	1	13	Y
A123	A3009	Product B	Average Daily Dose	ADD	2	7.4	Y
A123	A3009	Product B	Total Dose	TOTDOSE	3	96.2	Y

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ADEXSUM metadtaa

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Core	CDISC Notes
STUDYID	Study Identifier	Char		Req	ADEX.STUDYID
USUBJID	Unique Subject Identifier	Char		Req	ADEX.USUBJID
TRTA	Actual Treatment	Char		Cond	ADEX.TRT01A
PARAM	Parameter	Char		Req	Assigned
PARAMCD	Parameter Code	text		Req	Assigned
PARAMN	Parameter (N)	Num		Perm	Assigned
AVAL	Analysis Value	Num		Cond	see parameter level metadata
SAFFL	Safety Population Flag	Char	Y;N	Cond	ADSL.SAFFL

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ADaM Example.ADEX EX/EC Example 1