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Comment: Updated all dates to yymmdd10.

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Definexmltable

Dataset	ADSL
Level	Variable
Purpose	Analysis
Name	Variable

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Source/Derivation/Comment
STUDYID	Study Identifier	text		Predecessor: DM.STUDYID
USUBJID	Unique Subject Identifier	text		Predecessor: DM.USUBJID
BRTHDT	Date of Birth	integer	date9yymmdd10.	Derived: Date portion of DM.BRTHDTC converted to numeric and displayed in a format, such as date9yymmdd10.
AAGE	Analysis Age	float		Derived: Age as screening, computed by DM.RFICDTC - BRTHDTC as continuous variable. Note that some countries do not allow capturing date of birth, so this could be computed by capturing age in years and months on a CRF.
AGE	Age	integer		Predecessor: DM.AGE
AGEU	Age Units	text	YEARS	Predecessor: DM.AGEU
SEX	Sex	text	(SEX)	Predecessor: DM.SEX
RACE	Race	text	(RACE)	Predecessor: DM.RACE
TRTSDT	Date of First Exposure to Treatment	integer	date9yymmdd10.	Derived: Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as date9yymmdd10.
RFICDT	Date of Informed Consent	integer	date9yymmdd10.	Derived: Date portion of DM.RFICDTC converted to numeric and displayed in a format such as date9yymmdd10.
DTHDT	Date of Death	integer	date9yymmdd10.	Derived: Date portion of DM.DTHDT converted to numeric and displayed in a format such as date9yymmdd10.
DTHFL	Subject Death Flag	text	Y	Predecessor: DM.DTHFL
TRT01P	Planned Treatment for Period 01	text	Drug A; Drug B	Predecessor: DM.ARM. May be changed to lower case or more descriptive term for use in tables and listings.
TRT01A	Actual Treatment for Period 01	text	Drug A; Drug B	Predecessor: DM.ACTARM. Note: Actual treatment matches planned treatment unless there is a reason subject does not take planned drug.
ITTFL	Intent-To-Treat Population Flag	text	Y; N	Derived: Derive the intent-to-treat population as per the protocol and SAP.
ACEINHFL	ACE Inhibitor Medications Flag	text	Y; N	Derived: Select a list of ACE inhibitor medications from concomitant medications (CM) domain as per SAP or protocol. Set to "Y" if these medications were taken during the study, and "N" if they are absent. Can be used to subset or to exclude the population who took ACE inhibitors.
HEIGHTSC	Height (cm) at Screening	float		Predecessor: Set to VS.VSSTRESN where VS.VSTESTCD = "HEIGHT" and VISITNUM= 1 (or screening visit).
WEIGHTSC	Weight (kg) at Screening	float		Predecessor: Set to VS.VSSTRESN where VS.VSTESTCD = "WEIGHT" and VISITNUM = 1 (or screening visit).
BSASC	Body Surface Area at Screening	float		Derived: Select where VISITNUM = 1 (or screening visit). Compute from HEIGHT and WEIGHT, using the Du Bois method. BSA = 0.007184 × W^0.425 × H^0.725 There are multiple methods for calculating BSA (e.g., Du Bois, Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, Schlich); the study protocol should describe which to use.

13JUN2022

Dataset wrap

Show	true
Name	ADSL

16JUN2022

Dataset2

tableid	adsl

Row	STUDYID	USUBJID	BRTHDT	AAGE	AGE	AGEU	SEX	RACE	TRTSDT	RFICDT	DTHDT	DTHFL	TRT01P	ITTFL	ACEINHFL	HEIGHTSC	WEIGHTSC	BSASC
1	DMD-EFLGE	DMD-EF-01-101

07FEB2010

2010-02-07

12.3

YEARS

BLACK OR AFRICAN AMERICAN

16JUN2022

2022-06-16	2022-06-16			Drug A	Y	Y	119	20	0.82
2	DMD-EFLGE	DMD-EF-01-101

01MAY2008

2008-05-01

14.1

YEARS

ASIAN

13JUN2022

2022-06-13	2022-06-13			Drug A	Y	Y	115	30	0.95
3	DMD-EFLGE	DMD-EF-01-101

10JUL2003

2003-07-10

19.0

YEARS

NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

15JUL2022

2022-07-15	2022-07-15			Drug B	Y	N	140	45	1.30
4	DMD-EFLGE	DMD-EF-01-101

15JAN1999

1999-01-15

23.7

YEARS

WHITE

06SEP202206SEP202223NOV2023

2022-09-06

2023-11-23

Drug B

132

1.21

ADEFNTP

The ADEFNTP includes tests pertinent to analyses. The records from CV (CVTESTCD = "LVEF_C" and "RVEF_C") and the records from LB (LBTESTCD = "BNPPRONT") were selected. Many lab draws may occur throughout the year, but only those linked to a specific visit were included. By subsetting the LB dataset by LBLNKID not missing, laboratory data that aligns with CV data can be filtered out and sorted using USUBJID and VISIT. If LBLNKID is not available or the LB dataset does not contain VISIT, a windowing strategy could be used to select the laboratory draw closest to that visit using date of lab draw (LB.LBDTC.).

...

Definexmltable

Dataset	ADEFNTP
Level	Variable
Purpose	Analysis
Name	Variable

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Source/Derivation/Comment
STUDYID	Study Identifier	text		Predecessor: CV.STUDYID
USUBJID	Unique Subject Identifier	text		Predecessor: CV.USUBJID
BRTHDT	Date of Birth	integer	date9yymmdd10.	Predecessor: ADSL.BRTHDT
AAGE	Analysis Age	float		Predecessor: ADSL.AAGE
AGEU	Age Unit	text		Predecessor: ADSL.AGEU
SEX	Sex	text	(SEX)	Predecessor: ADSL.SEX
RACE	Race	text	(RACE)	Predecessor: ADSL.RACE
TRTSDT	Date of First Exposure to Treatment	integer	date9yymmdd10.	Predecessor: ADSL.TRTSDT
TRT01P	Planned Treatment for Period 01	text	Drug A; Drug B	Predecessor: ADSL.TRT01P
TRT01A	Actual Treatment for Period 01	text	Drug A; Drug B	Predecessor: ADSL.TRT01A
ITTFL	Intent-To-Treat Population Flag	text	Y; N	Predecessor: ADSL.ITTFL
HEIGHT	Height (cm)	float		Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit.
WEIGHT	Weight (kg)	float		Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit.
BSA	Body Surface Area (m2)	float		Derived: Compute from HEIGHT and WEIGHT at each visit, using the Du Bois method. BSA = 0.007184 × W^0.425 × H^0.725 There are multiple methods for calculating BSA; the study protocol should describe which to use.
ACEINHFL	ACE Inhibitor Medications Flag	text	Y; N	Predecessor: ADSL.ACEINHFL
PARAM	Parameter	text	Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%); N-Terminal ProB-type Natriuretic Peptide (ng/L)	Predecessor: CV.CVTEST LB.LBTEST
PARAMCD	Parameter Code	text	LVEF_C; RVEF_C; BNPPRONT	Predecessor: CV.CVTESTCD LB.LBTESTCD
PARAMN	Parameter (N)	integer	1; 2; 3	Assigned: Number PARAMCD as follows: LVEF_C = "1" RVEF_C = "2" BNPPRONT = "3"
AVAL	Analysis Value	float		See Parameter Value Metadata
AVISIT	Analysis Visit	text	Visit 1 (Baseline); Visit 6 (1 Year)	If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". If CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)".
AVISITN	Analysis Visit (N)	integer	1; 6	Predecessor: CV.VISITNUM LB.VISITNUM
VISIT	Visit	integer	VISIT 1; VISIT 6	Predecessor: CV.VISIT LB.VISIT
ADT	Analysis Date	integer	date9yymmdd10.	Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9yymmdd10.
ABLFL	Baseline Record Flag	text	Y	Derived: If CV.VISIT = "VISIT 1" then ABLFL = "Y".
BASE	Baseline Value	float		Derived: Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional visits by merging the value of BASE in the baseline record by USUBJID and PARAMCD.
CHG	Change from Baseline	float		Derived: Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records.
PCHG	Percent Change from Baseline	float		Derived: Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records.
CHGCAT1	Change from Baseline Category 1	text	Decline >=5%; Decline <5%; No decline	See Parameter Value Metadata
SRCDOM	Source Data	text	CV; LB	Assigned: Set to the SDTM domain name that relates to the analysis value.
SRCVAR	Source Variable	text	CVSTRESN; LBSTRESN	Assigned: Set to the SDTM variable that relates to the analysis value.
SRCSEQ	Source Sequence Number	integer		Predecessor: Set to the SDTM domain sequence number that relates to the analysis value, CV.CVSEQ or LB.LBSEQ.

...

Dataset wrap

Show	true
Name	ADEFNTP

Dataset2

tableid	adefntp

Row

STUDYID

USUBJID

AAGE

AGEU

SEX

RACE

TRT01P

TRT01A

ITTFL

HEIGHT

WEIGHT

BSA

ACEINHFL

PARAM

PARAMCD

PARAMN

AVAL

AVISIT

AVISITN

VISIT

ADT

ABLFL

BASE

CHG

PCHG

CHGCAT1

SRCDOM

SRCVAR

SRCSEQ

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

BLACK OR AFRICAN AMERICAN

Drug A

119

0.82

Left Ventricular Ejection Fraction, Cal (%)

LVEF_C

Visit 1 (Baseline)

VISIT 116MAY2022

2022-05-16

CVTESTCD

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-13

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

BLACK OR AFRICAN AMERICAN

Drug A

119

0.82

Right Ventricular Ejection Fraction, Cal (%)

RVEF_C

Visit 1 (Baseline)

VISIT 116MAY2022

2022-05-16

CVTESTCD

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

BLACK OR AFRICAN AMERICAN

Drug A

119

0.82

N-Terminal ProB-type Natriuretic Peptide (ng/L)

BNPPRONT

Visit 1 (Baseline)

VISIT 116MAY2022

2022-05-16

LBTESTCD

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

BLACK OR AFRICAN AMERICAN

Drug A

132

1.08

Left Ventricular Ejection Fraction, Cal (%)

LVEF_C

Visit 6 (1 Year)

VISIT 6

06APR2023

2023-04-23

-7

-10.447761

Decline >=5.0%

CVTESTCD

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

BLACK OR AFRICAN AMERICAN

Drug A

132

1.08

Right Ventricular Ejection Fraction, Cal (%)

RVEF_C

Visit 6 (1 Year)

VISIT 606APR2023

2023-04-23

-13

-17.567568

Decline >=5.0%

CVTESTCD

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

BLACK OR AFRICAN AMERICAN

Drug A

132

1.08

N-Terminal ProB-type Natriuretic Peptide (ng/L)

BNPPRONT

900

Visit 6 (1 Year)

VISIT 606APR2023

2023-04-23

860

2,150

Increase >100 ng/L

LBTESTCD

...

Definexmltable

Dataset	ADEFMRI
Level	Variable
Purpose	Analysis
Name	Variable

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Source/Derivation/Comment
STUDYID	Study Identifier	text		Predecessor: ADEFNTP.STUDYID
USUBJID	Unique Subject Identifier	text		Predecessor: ADEFNTP.USUBJID
BRTHDT	Date of Birth	integer	date9yymmdd10.	Predecessor: ADEFNTP.BRTHDT
AAGE	Analysis Age	float		Predecessor: ADEFNTP.AAGE
AGEU	Age Unit	text	YEARS	Predecessor: ADEFNTP.AGEU
SEX	Sex	text	(SEX)	Predecessor: ADEFNTP.SEX
RACE	Race	text	(RACE)	Predecessor: ADEFNTP.RACE
TRTSDT	Date of First Exposure to Treatment	Num	date9yymmdd10.	Predecessor: ADEFNTP.TRTSDT
TRT01P	Planned Treatment for Period 01	text	Drug A; Drug B	Predecessor: ADEFNTP.TRT01P
ITTFL	Intent-To-Treat Population Flag	text	Y; N	Predecessor: ADEFNTP.ITTFL
BSA	Body Surface Area (m2)	float		Predecessor: ADEFNTP.BSA
ACEINHFL	ACE Inhibitor Medications Flag	text	Y; N	Predecessor: ADEFNTP.ACEINHFL
BNPPRONT		integer		Derived: BNPPRONT = AVAL where PARAMCD = ADEFNTP.BNPPRONT, and merge by USUBJID and AVISITN. Note: There are many ways to add this including transposing the data.
PARAM	Parameter	text	Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%)	Predecessor: ADEFNTP.PARAM
PARAMCD	Parameter Code	text	LVEF_C; RVEF_C	Predecessor: ADEFNTP.PARAMCD
PARAMN	Parameter (N)	integer		Predecessor: ADEFNTP.PARAMN
AVAL	Analysis Value	float		Predecessor: ADEFNTP.AVAL
AVISIT	Analysis Visit	text	Visit 1 (Baseline); Visit 6 (1 Year)	Predecessor: ADEFNTP.AVISIT
AVISITN	Analysis Visit (N)	integer	1; 6	Predecessor: ADEFNTP.AVISITN
ADT	Analysis Date	float	date9yymmdd10.	Predecessor: ADEFNTP.ADT
ABLFL	Baseline Record Flag	text	Y	Predecessor: ADEFNTP.ABLFL
BASE	Baseline Value	float		Predecessor: ADEFNTP.BASE
CHG	Change from Baseline	float		Predecessor: ADEFNTP.CHG
PCHG	Percent Change from Baseline	float		Predecessor: ADEFNTP.PCHG
CHGCAT1	Change from Baseline Category 1	text	Decline >=5.0%; Decline <5.0%; Increase >100 ng/L	Predecessor: ADEFNTP.CHGCAT1

Dataset wrap

Show	true
Name	adefmri

Dataset2

tableid	adefmri

Row	STUDYID	USUBJID	BRTHDT	TRT01P	AAGE	AGU	SEX	RACE	TRT01A	ITTFL	BSA	ACEINHFL	BNPPRONT	PARAM	PARAMCD	PARAMN	AVAL	AVISIT	AVISITN	ADT	ABLFL	BASE	CHG	PCHG	CHGCAT1
1	DMD-EFLGE	DMD-EF-01-101	07FEB20102010-02-07	Drug A	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Y	0.82	Y	40	Left Ventricular Ejection Fraction, Cal (%)	LVEF_C	1	70	Visit 1 (Baseline)	116MAY2022	2022-05-16	Y	70
2	DMD-EFLGE	DMD-EF-01-101	07FEB20102010-02-07	Drug A	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Y	0.82	Y	40	Right Ventricular Ejection Fraction, Cal (%)	RVEF_C	2	75	Visit 1 (Baseline)	116MAY2022	2022-05-16	Y	75
3	DMD-EFLGE	DMD-EF-01-101	07FEB20102010-02-07	Drug A	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Y	1.08	Y	900	Left Ventricular Ejection Fraction, Cal (%)	LVEF_C	1	65	Visit 6 (1 Year)	606APR2023	2023-04-23		70	-5	-10.447761	Decline >=5.0%
4	DMD-EFLGE	DMD-EF-01-101	07FEB20102010-02-07	Drug A	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Y	1.08	Y	900	Right Ventricular Ejection Fraction, Cal (%)	RVEF_C	2	70	Visit 6 (1 Year)	606APR2023	2023-04-23		75	-5	-17.567568	Decline >=5.0%

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Key

ADEFNTP