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changes.mady.by.user Christine Connolly

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

dataset-wrap
Nameadex
ADY
Dataset2
tableidadex
RowSTUDYIDUSUBJID
ADT
ASTDTASTDYAENDTAENDYEXTRTDOSCUMAEXSTDTCEXENDTCTRTAEXDOSEEXDOSUSAFFL
1A123A2001
8-Jan-21
08JAN2021

1

14JAN2021

7

e-nicotine liquid

6

021-01-082021-01-14Placebo6mLY
2A123A2001

9-Jan-21

2e-nicotine liquid12021-01-082021-01-14Placebo6mLY
3A123A200110-Jan-213e-nicotine liquid18021-01-082021-01-14Placebo6mLY

15JAN2021

8

21JAN2021

14
4A123A200111-Jan-214
e-nicotine liquid
24
021-01-082021-01-14Placebo6mLY5A123A2001
12
-Jan-215e-nicotine liquid30021-01-082021-01-14Placebo6mLY6A123A200113-Jan-216e-nicotine liquid36021-01-082021-01-14Placebo6mLY7A123A200114-Jan-217e-nicotine liquid42021-01-082021-01-14Placebo6mLY8A123A200115-Jan-218e-nicotine liquid48
.42021-01-152021-01-21Placebo6.4mLY
9
3A123A2001
16-Jan-219e-nicotine liquid54.82021-01-152021-01-21Placebo6.4mLY10A123A200117-Jan-2110e-nicotine liquid61.22021-01-152021-01-21Placebo6.4mLY11A123A200118-Jan-2111e-nicotine liquid67.62021-01-152021-01-21Placebo6.4mLY12A123A200119-Jan-2112e-nicotine liquid742021-01-152021-01-21Placebo6.4mLY13A123A200120-Jan-2113e-nicotine liquid80.42021-01-152021-01-21Placebo6.4mLY14A123A200121-Jan-2114e-nicotine liquid86.82021-01-152021-01-21Placebo6.4mLY15A123A200122-Jan-2115e-nicotine liquid93.8

22JAN2021

15

28JAN2021

21e-nicotine liquid19.42021-01-222021-01-28Placebo7mLY
16A123A200123-Jan-2116e-nicotine liquid100.82021-01-222021-01-28Placebo7mLY17A123A200124-Jan-2117e-nicotine liquid107.82021-01-222021-01-28Placebo7mLY18A123A200125-Jan-2118e-nicotine liquid114.82021-01-222021-01-28Placebo7mLY19A123A200126-Jan-2119e-nicotine liquid121.82021-01-222021-01-28Placebo7mLY20A123A200127-Jan-2120e-nicotine liquid128.82021-01-222021-01-28Placebo7mLY21A123A200128-Jan-2121e-nicotine liquid135.82021-01-222021-01-28Placebo7mLY22A123A2008

8-Feb-21

1

e-nicotine liquid

5

2021-02-082021-02-14Product A5mLY23A123A20089-Feb-212e-nicotine liquid102021-02-082021-02-14Product A5mLY24A123A200810-Feb-213e-nicotine liquid15
4A123A2008

08FEB2021

1

14FEB2021

7

e-nicotine liquid52021-02-082021-02-14Product A5mLY
25A123A200811-Feb-214e-nicotine liquid202021-02-082021-02-14Product A26
5
mLY27A123A200813-Feb-216e-nicotine liquid302021-02-082021-02-14Product A5mLY28A123A200814-Feb-217e-nicotine liquid352021-02-082021-02-14Product A5mLY29A123A200815-Feb-218e-nicotine liquid422021-02-152021-02-21Product A7mLY30A123A200816-Feb-219e-nicotine liquid492021-02-152021-02-21Product A7mLY31A123A200817-Feb-2110e-nicotine liquid562021-02-152021-02-21Product A7mLY32A123A200818-Feb-2111e-nicotine liquid632021-02-152021-02-21Product A7mLY33A123A200819-Feb-2112e-nicotine liquid70
A123A2008
12-Feb-215e-nicotine liquid252021-02-082021-02-14Product A5mLY
15FEB2021821FEB202114e-nicotine liquid12
2021-02-152021-02-21Product A7mLY
34
6A123A2008
20-Feb-2113e-nicotine liquid772021-02-152021-02-21Product A7mLY35A123A200821-Feb-2114e-nicotine liquid842021-02-152021-02-21Product A7mLY36A123A200822-Feb-2115e-nicotine liquid922021-02-222021-03-01Product A8mLY37A123A200823-Feb-2116e-nicotine liquid1002021-02-222021-03-01Product A8mLY38A123A200824-Feb-2117e-nicotine liquid1082021-02-222021-03-01Product A8mLY39A123A200825-Feb-2118e-nicotine liquid1162021-02-222021-03-01Product A8mLY40A123A200826-Feb-2119e-nicotine liquid1242021-02-222021-03-01Product A8mLY41A123A200827-Feb-2120e-nicotine liquid132
22FEB20211501MAR202122e-nicotine liquid202021-02-222021-03-01Product A8mLY
4243A123A20081-Mar-21

22

e-nicotine liquid1482021-02-222021-03-01Product A8mLY44A123A30099-Jun-21

1

7A123
A200828-Feb-2121e-nicotine liquid1402021-02-222021-03-01Product A8mLY
A300909JUN2021

1

15JUN2021

7

e-nicotine liquid82021-06-092021-06-15Product B8mLY
45A123A300910-Jun-212e-nicotine liquid162021-06-092021-06-15Product B
8
mL46
Y
A123A3009
11-Jun-213e-nicotine liquid242021-06-092021-06-15Product B8mLY47A123A300912-Jun-214e-nicotine liquid322021-06-092021-06-15Product B8mLY48A123A300913-Jun-215
16JUN2021821JUN202113
e-nicotine liquid
40
2021-06-092021-06-15Product B8mLY49A123A3009
14
-Jun-216e-nicotine liquid482021-06-092021-06-15Product B8mLY50A123A300915-Jun-217e-nicotine liquid562021-06-092021-06-15Product B8mLY51A123A300916-Jun-218e-nicotine liquid62
.72021-06-162021-06-21Product B6.7mLY
52
A123
Definexmltable
Dataset
A300917-Jun-219e-nicotine liquid69.42021-06-162021-06-21Product B6.7mLY
53A123A300918-Jun-2110e-nicotine liquid76.12021-06-162021-06-21Product B6.7mLY
54A123A300919-Jun-2111e-nicotine liquid82.82021-06-162021-06-21Product B6.7mLY
55A123A300920-Jun-2112e-nicotine liquid89.52021-06-162021-06-21Product B6.7mLY
56A123A300921-Jun-2113e-nicotine liquid96.22021-06-162021-06-21Product B6.7mLY
ADEX
LevelDataset
PurposeAnalysis
NameADEX
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADEXExposure Analysis DatasetOCCURRENCE DATA STRUCTUREOne record per subject per product (EXTRT) per start dateAnalysisSTUDYID, USUBJID, EXTRT, ASTDTADEX.xptADEX.SAS/SAP
Definexmltable
Definexmltable
DatasetADEX
LevelVariable
PurposeAnalysis
NameADEX

Variable Name

Variable LabelTypeCodelist/Controlled TermsCoreCDISC Notes
STUDYIDStudy Identifiertext
ReqEX.STUDYID
USUBJIDUnique Subject Identifiertext
ReqEX.USUBJID
ADT
ASTDTAnalysis Start Date

integer


Perm
create a value for every date from

EX.EXSTDTC

to

cpatured as a numeric variable

ASTDYAnalysis Start Relative Dayinteger
PermASTDT-ADT.TRTSDT+1
AENDTAnalysis End Dateinteger
PermEX.EXENDTC cpatured as a numeric variable
ADY
AENDYAnalysis
Start
End Relative Dayinteger
PermAENDT-ADT.TRTSDT+1
EXTRTName of

Treatment
Producttext
ReqEX.EXTRT
DOSCUMA

Cumulative Actual

Treatment

Product Dose

float
PermCumulative dose within USUBJID
EXSTDTCStart Date/Time

of
Treatment
Producttext
PermEX.EXSTDTC
EXENDTCEnd Date/Time of Product
Treatment
text
PermEX.EXENDTC
TRTAActual
Treatment
Producttext
CondADSL.TRT01A
EXDOSEDosefloat
PermEX.EXDOSE
EXDOSUDose Unitstext
PermEX.EXDOSU
SAFFL

Safety Population Flag

text
CondADSL.SAFFL

...

Dataset wrap

...

Name

...

STUDYID

...

adexsum

...

Dataset2
tableidadexsum
Row
STUDYIDUSUBJID

...

TRTA

...

PARAM

...

PARAMCD

...

PARAMN

...

AVAL

...

ADEXSUM data

...

TRTA

...

PARAM

...

PARAMCD

...

PARAMN

...

AVAL

...

SAFFL

SAFFL

1A123A2001

Placebo

Number of

...

Days Exposed

...

NDAYS

1

21

Y

2A123A2001

Placebo

Average Daily Dose

ADD

2

...

0.

...

92381Y
3A123A2001

Placebo

Total Dose

TOTDOSE

3

...

19.

...

4Y
4A123A2008

Product A

Number of

...

Days Exposed

...

NDAYS

1

22Y
5A123A2008

Product A

Average Daily Dose

ADD

2

...

0.

...

90909Y
6A123A2008

Product A

Total Dose

TOTDOSE

3

...

20Y
7A123A3009

Product B

Number of

...

Days Exposed

...

NDAYS

1

13Y
8A123A3009

Product B

Average Daily Dose

ADD

2

...

1.

...

13077Y
9A123A3009

Product B

Total Dose

TOTDOSE

3

...

14.7Y
Definexmltable
LevelDataset
PurposeAnalysis
NameADEXSUM
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADEXSUMExposure Summary Analysis DatasetBASIC DATA STRUCTUREOne or more records per subject per analysis parameterAnalysisSTUDYID, USUBJID, PARAMADEXSUM.xptADEXSUM.SAS/SAP
Definexmltable
DatasetADEXSUM
LevelVariable
PurposeAnalysis
NameADEXSUM
Variable NameVariable LabelTypeCodelist/Controlled TermsCoreCDISC Notes

STUDYID

Study IdentifierChar
ReqADEX.STUDYID
USUBJIDUnique Subject IdentifierChar
ReqADEX.USUBJID
TRTAActual ProductChar
CondADEX.TRT01A
PARAMParameterChar
ReqAssigned
PARAMCDParameter Codetext
ReqAssigned
PARAMNParameter (N)Num
PermAssigned
AVALAnalysis ValueNum
Condsee parameter level metadata
SAFFLSafety Population FlagCharY;NCondADSL.SAFFL

...