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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

date9.

Derived: Date portion of DM.BRTHDTC converted to numeric and displayed in a format such as date9.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-5

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

date9.

Derived: Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as date9.

RFICDT

Date of Informed Consent

integer

date9.

Derived: Date portion of DM.RFICDTC converted to numeric and displayed in a format such as date9.

DTHDT

Date of Death

integer

date9.

Derived: Date portion of DM.DTHDT

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-6

converted to numeric and displayed in a format such as date9.

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.

...

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-8

In this example, variables BASE, CHG, PCHG, and CHGCAT1 were added to facilitate analyses of the efficacy endpoints.

Definexmltable

Dataset	ADCVNTP
Level	ValueVariable
Purpose	Analysis
Name	AVALVariable

Variable Name	WhereVariable Label	Type	Origin	Codelist/Controlled Terms	Source/Derivation/Comment
AVAL	PARAMCD in ("LVEF_C", "RVEF_C")	float	Predecessor	CV.CVSTRESN
AVAL	PARAMCD = "BNPPRONT"	float	Predecessor	LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT"

Definexmltable

Dataset	ADCVNTP
Level	Value
Purpose	Analysis
Name	CHGCAT1

STUDYID

Study Identifier

text

Predecessor: CV.STUDYID

USUBJID

Unique Subject Identifier

text

Predecessor: CV.USUBJID

BRTHDT

Date of Birth

integer

date9.

Predecessor: ADSL.BRTHDT

AAGE

Analysis Age

float

Predecessor: ADSL.AAGE

AGEU

Age Unit

text

Predecessor: ADSL.AGEU

SEX

Sex

text

(SEX)

Predecessor: ADSL.SEX

Variable

Where

Type

Origin

Derivation/Comment

CHGCAT1

PARAMCD in ("LVEF_C", "RVEF_C")

text

Derived

Categorize the value of CHGCAT1 as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=5%".

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-9

Else if CHG not missing and CHG < 5.00 THEN CHGCAT1 = "Decline <5%"

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-10

CHGCAT1

PARAMCD = "BNPPRONT"

text

Derived

Categorize the value of CHCAT1 as follows: "Increase >100 ng/L"; "Increase <=100 ng/L"; "No increase"

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-11

Definexmltable

Dataset	ADCVNTP
Level	Variable
Purpose	Analysis
Name	Variable

16

RACE

Race

text

(RACE)

Predecessor: ADSL.RACE

TRTSDT

Date of First Exposure to Treatment

integer

date9

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

date9.

Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9.

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

Assigned: Set to the SDTM variable that relates to the analysis value.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-12

SRCSEQ

Source Sequence Number

integer

Predecessor:

CV.CVSEQ

LB.LBSEQ

Set to the SDTM domain sequence number that relates to the analysis value.

In this example, variables BASE, CHG, PCHG, and CHGCAT1 were added to facilitate analyses of the efficacy endpoints. the variables SRCDOM, SRCVAR, and SRCSEQ provide traceability to the combined source datasets. Thes tables below represent parameter value level lists for applicable variables.

Definexmltable

Dataset	ADCVNTP
Level	Value
Purpose	Analysis
Name	AVAL

Variable	Where	Type	Origin	Derivation/Comment
AVAL	PARAMCD in ("LVEF_C", "RVEF_C")	float	Predecessor	CV.CVSTRESN
AVAL	PARAMCD = "BNPPRONT"	float	Predecessor	LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT"

Definexmltable

Dataset	ADCVNTP
Level	Value
Purpose	Analysis
Name	CHGCAT1

Predecessor: ADSL.AGEU

Assigned: Set to the SDTM variable that relates to the analysis value.12

Predecessor:

CV.CVSEQ

LB.LBSEQ

Set to the SDTM domain sequence number that relates to the analysis value.

Variable

Where

Type

Origin

Derivation/Comment

CHGCAT1

PARAMCD in ("LVEF_C", "RVEF_C")

text

Derived

Categorize the value of CHGCAT1 as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=5%".

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-9

Else if CHG GT 0 and CHG < 5.00 THEN CHGCAT1 = "Decline <5%"

Else if CHG <0 then CHGCAT1 = No Decline.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-10

CHGCAT1

PARAMCD = "BNPPRONT"

text

Derived

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

date9.

Predecessor: ADSL.BRTHDT

AAGE

Analysis Age

float

Predecessor: ADSL.AAGE

AGEU

Age Unit

text

SEX

Sex

text

(SEX)

Predecessor: ADSL.SEX

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TAUGDMDCIS-16

RACE

Race

text

(RACE)

Predecessor: ADSL.RACE

TRTSDT

Date of First Exposure to Treatment

integer

date9

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

date9.

Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9.

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%; Increase GT 100 ng/L

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

Categorize the value of CHCAT1 as follows: "Increase >100 ng/L"; "Increase <=100 ng/L"; "No increase"

Jira

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

SRCSEQ

Source Sequence Number

integer

11

Dataset wrap

Show	true
Name	adcvntp

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

1

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

119

20

0.82

Y

Left Ventricular Ejection Fraction, Cal (%)

LVEF_C

1

67

Visit 1 (Baseline)

1

VISIT 1

16MAY2022

Y

67

CV

CVTESTCD

Jira

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

3

2

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

119

20

0.82

Y

Right Ventricular Ejection Fraction, Cal (%)

RVEF_C

2

74

Visit 1 (Baseline)

1

VISIT 1

16MAY2022

Y

74

CV

CVTESTCD

7

3

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

119

20

0.82

Y

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

BNPPRONT

3

40

Visit 1 (Baseline)

1

VISIT 1

16MAY2022

Y

40

LB

LBTESTCD

1

4

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

132

32

1.08

Y

Left Ventricular Ejection Fraction, Cal (%)

LVEF_C

1

60

Visit 6 (1 Year)

6

VISIT 6

06APR2023

67

-7

-10.447761

Decline >=5.0%

CV

CVTESTCD

11

5

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

132

32

1.08

Y

Right Ventricular Ejection Fraction, Cal (%)

RVEF_C

2

61

Visit 6 (1 Year)

6

VISIT 6

06APR2023

74

-13

-17.567568

Decline >=5.0%

CV

CVTESTCD

15

6

DMD-EFLGE

DMD-EF-01-101

12.3

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

132

32

1.08

Y

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

BNPPRONT

3

900

Visit 6 (1 Year)

6

VISIT 6

06APR2023

40

860

2,150

Increase >100 ng/L

LB

LBTESTCD

2

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