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

dataset-wrap

Name	adex

Dataset2

tableid	adex

Row	STUDYID	USUBJID	ASTDT	ASTDY	AENDTADT	ADYAENDY	EXTRT	DOSCUMA	EXSTDTC	EXENDTC	TRTA	EXDOSE	EXDOSU	SAFFL
1	A123	A2001	8-Jan-2108JAN2021	1	14JAN2021	7	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
15JAN2021	8	21JAN2021	14	e-nicotine liquid	12	8	A123	A2001	15-Jan-21	8	e-nicotine liquid	48.4	2021-01-15	2021-01-21	Placebo	6.4	mL	Y
93	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
22JAN2021	15	28JAN2021	21	e-nicotine liquid	19.4	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
4	A123	A2008	08FEB2021	1	14FEB2021	7	e-nicotine liquid	5	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
15FEB2021	8	21FEB2021	14	e-nicotine liquid	12	33	A123	A2008	19-Feb-21	12	e-nicotine liquid	70	2021-02-15	2021-02-21	Product A	7	mL	Y
346	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
22FEB2021	15	01MAR2021	22	e-nicotine liquid	20	41	A123	A2008	27-Feb-21	20	e-nicotine liquid	132	2021-02-22	2021-03-01	Product A	8	mL	Y
427	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
A3009	09JUN2021	1	15JUN2021	7	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
16JUN2021	8	21JUN2021	13	e-nicotine liquid	14	51	A123	A3009	16-Jun-21	8	e-nicotine liquid	62.7	2021-06-16	2021-06-21	Product B	6.7	mL	Y52

A123

Definexmltable

Dataset

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

ADEX
Level	Dataset
Purpose	Analysis
Name	ADEX

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADEX	Exposure Analysis Dataset	OCCURRENCE DATA STRUCTURE	One record per subject per product (EXTRT) per start date	Analysis	STUDYID, USUBJID, EXTRT, ASTDT	ADEX.xpt	ADEX.SAS/SAP

Definexmltable

Dataset	ADEX

Level	Variable
Purpose	Analysis
Name	ADEX

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Core	CDISC Notes
STUDYID	Study Identifier	text		Req	EX.STUDYID
USUBJID	Unique Subject Identifier	text		Req	EX.USUBJID

ADT

ASTDT

Analysis Start Date

integer

Perm

create a value for every date from

EX.EXSTDTC

to

cpatured as a numeric variable
ASTDY	Analysis Start Relative Day	integer	Perm	ASTDT-ADT.TRTSDT+1
AENDT	Analysis End Date	integer	Perm	EX.EXENDTC cpatured as a numeric variable

ADY

AENDY

Analysis

Start

End Relative Day	integer		Perm	AENDT-ADT.TRTSDT+1
EXTRT	Name of Product

Treatment

text		Req	EX.EXTRT
DOSCUMA	Cumulative Actual

Treatment

Product Dose	float		Perm	Cumulative dose within USUBJID
EXSTDTC	Start Date/Time

of

Treatment

Product	text		Perm	EX.EXSTDTC
EXENDTC	End Date/Time of Product

Treatment

text		Perm	EX.EXENDTC
TRTA	Actual

Treatment

Product	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

Dataset wrap

Name	adexsum

Dataset2

tableid	adexsum

Row	STUDYID	USUBJID	TRTA	PARAM	PARAMCD	PARAMN	AVAL	SAFFL
1	A123	A2001	Placebo	Number of DosesDays Exposed	NDOSESNDAYS	1	21	Y
2	A123	A2001	Placebo	Average Daily Dose	ADD	2	60.46666792381	Y
3	A123	A2001	Placebo	Total Dose	TOTDOSE	3	13519.84	Y
4	A123	A2008	Product A	Number of DosesDays Exposed	NDOSESNDAYS	1	22	Y
5	A123	A2008	Product A	Average Daily Dose	ADD	2	60.72727390909	Y
6	A123	A2008	Product A	Total Dose	TOTDOSE	3	14820	Y
7	A123	A3009	Product B	Number of DosesDays Exposed	NDOSESNDAYS	1	13	Y
8	A123	A3009	Product B	Average Daily Dose	ADD	2	71.413077	Y
9	A123	A3009	Product B	Total Dose	TOTDOSE	3	9614.27	Y

Definexmltable

Level	Dataset
Purpose	Analysis
Name	ADEXSUM

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADEXSUM	Exposure Summary Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter	Analysis	STUDYID, USUBJID, PARAM	ADEXSUM.xpt	ADEXSUM.SAS/SAP

Definexmltable

Dataset	ADEXSUM
Level	Variable
Purpose	Analysis
Name	ADEXSUM

Variable Name	Variable Label	Type	Core	CDISC Notes
STUDYID	Study Identifier	Char	Req	ADEX.STUDYID
USUBJID	Unique Subject Identifier	Char	Req	ADEX.USUBJID
TRTA	Actual

Treatment

Product	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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