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changes.mady.by.user Christine Connolly

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New Version 16

changes.mady.by.user Nate Freimark

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Dataset wrap
Nameadex
Dataset2
2021-02-08
RowSTUDYIDUSUBJIDADTASTDTASTDYAENDTAENDYADYEXTRTDOSCUMAEXSTDTCEXENDTCTRTAEXDOSEEXDOSUSAFFL
1A123A20018-Jan-2108JAN2021

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
4A123A200111-Jan-214e-nicotine liquid24021-01-082021-01-14Placebo6mLY
5A123A200112-Jan-215e-nicotine liquid30021-01-082021-01-14Placebo6mLY
6A123A200113-Jan-216e-nicotine liquid36021-01-082021-01-14Placebo6mLY
7A123A200114-Jan-217e-nicotine liquid42021-01-082021-01-14Placebo6mLY

15JAN2021

8

21JAN2021

14e-nicotine liquid128A123A200115-Jan-218e-nicotine liquid48.42021-01-152021-01-21Placebo6.4mLY
93A123A200116-Jan-219e-nicotine liquid54.82021-01-152021-01-21Placebo6.4mLY
10A123A200117-Jan-2110e-nicotine liquid61.22021-01-152021-01-21Placebo6.4mLY

22JAN2021

15

28JAN2021

2111A123A200118-Jan-2111e-nicotine liquid67.62021-01-152021-01-21Placebo6.4mLY12A123A200119-Jan-2112e-nicotine liquid742021-01-152021-01-21Placebo6.4mLY
13A123A200120-Jan-2113e-nicotine liquid80.42021-01-152021-01-21Placebo6.4mLY
14A123A200121-Jan-2114e-nicotine liquid86.82021-01-152021-01-21Placebo6.4mLY15A123A200122-Jan-2115e-nicotine liquid93.82021-01-222021-01-28Placebo7mLY
16A123A200123-Jan-2116e-nicotine liquid100.82021-01-222021-01-28Placebo7mLY
17A123A200124-Jan-2117e-nicotine liquid107.82021-01-222021-01-28Placebo7mLY
18A123A200125-Jan-2118e-nicotine liquid114.82021-01-222021-01-28Placebo7mLY
19A123A200126-Jan-2119e-nicotine liquid121.82021-01-222021-01-28Placebo7mLY
20A123A200127-Jan-2120e-nicotine liquid128.82021-01-222021-01-28Placebo7mLY
21A123A200128-Jan-2121e-nicotine liquid135.82021-01-222021-01-28Placebo7mLY
22A123A2008

8-Feb-21

1

e-nicotine liquid

5

2021-02-082021-02-14Product A5mLY
23A123A20089-Feb-212e-nicotine liquid102021-02-082021-02-14Product A5mLY
4A123A2008

08FEB2021

1

14FEB2021

7

e-nicotine liquid524A123A200810-Feb-213e-nicotine liquid152021-02-082021-02-14Product A5mLY25A123A200811-Feb-214e-nicotine liquid20
2021-02-14Product A5mLY26A123A200812-Feb-215e-nicotine liquid252021-02-082021-02-14Product A5mLY
27A123A200813-Feb-216e-nicotine liquid302021-02-082021-02-14Product A5mLY
28A123A200814-Feb-217e-nicotine liquid352021-02-082021-02-14Product A5mLY
29A123A200815-Feb-218e-nicotine liquid422021-02-152021-02-21Product A7mLY
30A123A200816-Feb-219e-nicotine liquid492021-02-152021-02-21Product A7mLY
31A123A200817-Feb-2110e-nicotine liquid562021-02-152021-02-21Product A7mLY
32A123A200818-Feb-2111e-nicotine liquid632021-02-152021-02-21Product A7mLY
15FEB2021821FEB202114e-nicotine liquid1233A123A200819-Feb-2112e-nicotine liquid702021-02-152021-02-21Product A7mLY
346A123A200820-Feb-2113e-nicotine liquid772021-02-152021-02-21Product A7mLY
35A123A200821-Feb-2114e-nicotine liquid842021-02-152021-02-21Product A7mLY
36A123A200822-Feb-2115e-nicotine liquid922021-02-222021-03-01Product A8mLY
37A123A200823-Feb-2116e-nicotine liquid1002021-02-222021-03-01Product A8mLY
38A123A200824-Feb-2117e-nicotine liquid1082021-02-222021-03-01Product A8mLY
39A123A200825-Feb-2118e-nicotine liquid1162021-02-222021-03-01Product A8mLY
40A123A200826-Feb-2119e-nicotine liquid1242021-02-222021-03-01Product A8mLY
22FEB20211501MAR202122e-nicotine liquid2041A123A200827-Feb-2120e-nicotine liquid1322021-02-222021-03-01Product A8mLY
427A123A200828-Feb-2121e-nicotine liquid1402021-02-222021-03-01Product A8mLY
43A123A20081-Mar-21

22

e-nicotine liquid1482021-02-222021-03-01Product A8mLY
A300909JUN2021

1

15JUN2021

7

44A123A30099-Jun-21

1

e-nicotine liquid82021-06-092021-06-15Product B8mLY45A123A300910-Jun-212e-nicotine liquid162021-06-092021-06-15
Product B8mLY46A123A300911-Jun-213e-nicotine liquid242021-06-092021-06-15Product B8mLY
47A123A300912-Jun-214e-nicotine liquid322021-06-092021-06-15Product B8mLY
16JUN2021821JUN20211348A123A300913-Jun-215e-nicotine liquid402021-06-092021-06-15Product B8mLY49A123A300914-Jun-216e-nicotine liquid482021-06-092021-06-15Product B8mLY
50A123A300915-Jun-217e-nicotine liquid562021-06-092021-06-15Product B8mLY
51A123A300916-Jun-218e-nicotine liquid62.72021-06-162021-06-21Product B6.7mLY52A123A300917-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
Definexmltable
LevelVariable
PurposeAnalysis
NameADEX

Variable Name

Variable LabelTypeCodelist/Controlled TermsCoreCDISC Notes
STUDYIDStudy Identifiertext
ReqEX.STUDYID
USUBJIDUnique Subject Identifiertext
ReqEX.USUBJID
ADTASTDTAnalysis 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
ADYAENDYAnalysis Start End Relative Dayinteger
PermAENDT-ADT.TRTSDT+1
EXTRTName of
Treatment		text
ReqEX.EXTRT
DOSCUMA

Cumulative Actual Treatment Dose

float
PermCumulative dose within USUBJID
EXSTDTCStart Date/Time
of Treatment		text
PermEX.EXSTDTC
EXENDTCEnd Date/Time of
Treatment		text
PermEX.EXENDTC
TRTAActual Treatmenttext
CondADSL.TRT01A
EXDOSEDosefloat
PermEX.EXDOSE
EXDOSUDose Unitstext
PermEX.EXDOSU
SAFFL

Safety Population Flag

text
CondADSL.SAFFL
Dataset wrap
Nameadexsum
Dataset2
tableidadexsum
RowSTUDYIDUSUBJID

TRTA

PARAM

PARAMCD

PARAMN

AVAL

SAFFL

1A123A2001

Placebo

Number of Doses

NDOSES

1

21

Y

2A123A2001

Placebo

Average Daily Dose

ADD

2

6.466667Y
3A123A2001

Placebo

Total Dose

TOTDOSE

3

135.8Y
4A123A2008

Product A

Number of Doses

NDOSES

1

22Y
5A123A2008

Product A

Average Daily Dose

ADD

2

6.727273Y
6A123A2008

Product A

Total Dose

TOTDOSE

3

148Y
7A123A3009

Product B

Number of Doses

NDOSES

1

13Y
8A123A3009

Product B

Average Daily Dose

ADD

2

7.4Y
9A123A3009

Product B

Total Dose

TOTDOSE

3

96.2Y
Definexmltable
LevelVariable
PurposeAnalysis
NameADEXSUM
Variable NameVariable LabelTypeCodelist/Controlled TermsCoreCDISC Notes

STUDYID

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