Versions Compared

Old Version 79

changes.mady.by.user Karin LaPann

Saved on

compared with

New Version Current

changes.mady.by.user Karin LaPann

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: changed multivariat to multiple covariates

...

Ejection Fraction

  • change in ejection fraction, would expect a decline in EF of 2-3% per year, concerning if rapid progression, i.e., 10% decline or more

NTproBNP

  • % change over a period of time – a decrease is correlated with improvement, measured annually

...

Measuring LVEF regularly can show the rate of decline in left ventricle function for a patient with DMD. Therefore, it was selected as an endpoint for this example to measure whether a course of therapy may slow the progression of heart failure for the patient. The second endpoint chosen, NT-proBNP, is a biomarker that may be used to predict or diagnose heart failure.

This section illustrates example analysis datasets for the following endpoints:

  • Percent change in ejection fraction over time (1 year)
  • Decline in ejection fraction over time (1 year) grouped by a decline greater than 10-5.0%
  • Percent change in NTproBNP NT-proBNP over time (1 year)

Source Data

The SDTM examples used as the source data are from Section 2.1, Basic CMR Tests for Systolic Function. The CV dataset contains 16 rows, 1-8 for visit 1 and 9-16 for visit 6. Of these rows, the records in the CV dataset for which CVTESTCD = "LVEF_C" and CVTESTCD = "RVEF_C" representing the Ventricular Ejection Fraction, Calculated (%) for left and right were selected for the analysis. The records in the LB dataset test where LBTESTCD = "BNPPRONT" was used to add the value of BNPPRONT were used to compute the percent change over time , and then it was added as a potential covariate in each row for the last analysis. Both SDTM domains are used in one analysis dataset to demonstrate the flexibility of ADaM and to show that the various SDTM domains can be combined into one dataset both as rows and also as covariates.

Example Analysis Datasets

The following tables below show the analysis dataset metadata and metadata and parameters used for this example.

-

Definexmltable
Multipletrue
LevelDataset
PurposeAnalysis

Dataset Name

Dataset Description

Class of Dataset

Structure

LocationPurpose

Keys

Location

Documentation

ADSL

Subject-Level Analysis Dataset

SUBJECT LEVEL ANALYSIS DATASET

One record per subject.

AnalysisUSUBJIDadsl.xptUSUBJIDADSL.SASADaMIG
ADEFNTPCV MRI EF and NT-proBNP AnalysisADCVNTPCardiac Ejection Fraction and NTproBNP Analysis Dataset

BASIC DATA STRUCTURE

One record per subject per analysis visit per parameter.adcvntp.xptAnalysisUSUBJID, AVISITN, PARAMN

Analysis Dataset

adefntp.xpt

ADEFNTP.SAS/SAP

ADEFMRICV MRI ADCVCMRCardiovascular CMR Ejection Fraction Analysis Dataset

BASIC DATA STRUCTURE

One record per subject per analysis visit per parameter.adcvcmr.xptAnalysisUSUBJID, AVISITN, PARAMN

Analysis Dataset

adefmri.xpt

ADEFMRI.SAS/SAP

ADSL

The ADSL contains subject characteristics and covariates that are important for analyses. Stratification variables can be The ADSL was combined with other SDTM datasets to create the analysis datasets. More than one SDTM dataset can be combined in this way. Also, stratification variables can be created in the ADSL to subset by, or to add variables needed in the analyses. For example, a flag (ACEMEDFL) could be added for ACE inhibitors. Another variable, body surface area (BSABL), was derived from the LB dataset at the baseline visit and added to ADSL.

The ADCVNTP dataset includes tests pertinent to these analyses. The records from LB where CVTESTCD is equal to "LVEF_C" or "RVEF_C" and LBTESTCD = "BNPPRONT" were selected. The relationship dataset RELREC illustrates the relationship between datasets. In this case, many lab draws may occur throughout the year, but only those linked to a specific visit are included. By subsetting the LB dataset with 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, a windowing strategy could be used to select the laboratory draw closest to that visit for merging with CV, computed in AVISIT. In the example, only two LB records are shown which are linked to CV where CVTESTCD = "LVEF_C" or CVTESTCD = "R.VEF_C".

ADCVMR is an efficacy analysis dataset with only a few records for more complex modeling of changes in ejection fraction, plus the ProB-type test results. It is an ADaM Basic Data Structure (BDS) dataset, with additional variables added from ADCVNTP.

ADSL Analysis Dataset

This is a simplified example ADSL dataset; it is expected that additional variables for stratification or of interest for analysis would be included.

the data. More than one SDTM dataset may be used as input to the ADSL. This is a simplified example ADSL dataset; the ADaMIG should be referenced for additional variables.

For this example:

  • Analysis age (AAGE) was included to provide age with more precision.
  • A flag indicating the use of ACE inhibitors (ACEINHFL) is shown with example derivation from the CM dataset.
  • Body surface area at screening (BSASC) was derived from the VS dataset using height and weight at the screening visit. There are many possible calculations for BSA; for this example, the Du Bois method was used.[11] Note that the screening visit and visit 1 occurred at the same time in this example.
Date portion of DM.RFSTDTC converted
Definexmltable
DatasetADSL
LevelVariable
PurposeAnalysis
NameVariable
Variable NameVariable LabelTypeCodelist/Controlled TermsSource/Derivation/Comment
STUDYIDStudy Identifiertext
Predecessor: DM.STUDYID
USUBJIDUnique Subject Identifiertext
Predecessor: DM.USUBJID
BRTHDTDate of Birthintegeryymmdd10.

Derived: Date portion of DM.BRTHDTC converted to numeric and displayed in a format, such as yymmdd10. 

AAGEAnalysis Agefloat
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.
AGEAgeinteger
Predecessor: DM.AGE
AGEUAge UnitstextYEARSPredecessor: DM.AGEU

SEX

Sextext(SEX)Predecessor: DM.SEX

RACE

Racetext(RACE)Predecessor: DM.RACE
TRTSDTDate of First Exposure to Treatmentintegeryymmdd10.Derived: Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as yymmdd10.
RFICDT

Date of Informed Consent

integeryymmdd10.Derived: Date portion of DM.RFICDTC converted to numeric and displayed in a format such as yymmdd10.
DTHDT

Date of Death

integeryymmdd10.

Derived: Date portion of DM.DTHDT converted

Definexmltable
DatasetADSL
LevelVariable
PurposeAnalysis
NameVariable
Variable NameVariable LabelTypeCodelist/Controlled Terms/FormatSourceDerivation/Comment
STUDYIDStudy IdentifierChar

DM.STUDYID

USUBJIDUnique Subject IdentifierChar

DM.USUBJID

BRTHDTDate of BirthNumdate9.

ADSL.BRTHDTC

Convert BRTHDTC from ISO 8601 format to numeric date. (Note that if exact date is not found then use two variables to capture year and month.)
TRTSDTDate of First Exposure to TreatmentNumdate9.

to numeric and displayed in a format such as

DATE9.

yymmdd10.

DTHFL

Subject Death
Flag

textYPredecessor: DM.DTHFL
TRT01P

Planned Treatment for Period 01

Char
text
Treatment
Drug A
ADSL.TRT01P
; 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

textDrug A; Drug B

Predecessor: DM.ACTARM.

Note: Actual treatment matches planned treatment unless there is a reason subject does not take planned drug.

For this example we are using "Treatment A". In a Real World Evidence study this could be non-treatment related, e.g. "Group A".

ITTFL

Intent-To-Treat Population Flag

Char

text

Y; N

ADSL.ITTFL

Derived: Derive the intent-to-treat population as per the protocol and SAP.
BSABASEBody Surface Area (m2) at BaselineNumADSL.BSABASE

Set to VS.VSSTRESN in ADSL where VS.VSTESTCD = "BSA" and select for baseline visit.

ACEINHFL

ACE Inhibitor Medications Flag

Char

Y

ACEINHFL

ACE Inhibitor Medications Flag

text

Y; N

Derived: Select a list of ACE inhibitor medications from concomitant medications (CM) domain

, and from treatment (EX or EC) domains. Code

as per SAP or protocol. Set to "Y" if

the medication was

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.

Dataset wrap
Showtrue
NameADSL
Dataset2
tableidadsl
RowSTUDYIDUSUBJIDBRTHDTTRTSDTTRT01PITTFLBSABASEACENHFL1DMD-EFLGEDMD-EFLGE-10115FEB201315FEB2022Treatment AY0.65Y

ADCVNTP Analysis Dataset

In this example, columns for derived variables BASE, CHG, PCHG and CHGCAT1 have been added to facilitate analyses of the efficacy endpoints. Specifically, example demographic data for ADSL were created for an 8 year old male. Also, a custom variable for BSA at baseline (BSABASE), and an example of a stratification variable for subjects with was added from ADSL.

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 × W0.425 × H0.725

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.

Dataset wrap
Showtrue
NameADSL
Dataset2
tableidadsl
RowSTUDYIDUSUBJIDBRTHDTAAGEAGEAGEUSEXRACETRTSDTRFICDTDTHDTDTHFLTRT01PITTFLACEINHFLHEIGHTSCWEIGHTSCBSASC
1DMD-EFLGEDMD-EF-01-1012010-02-0712.312YEARSMBLACK OR AFRICAN AMERICAN2022-06-162022-06-16

Drug AYY119200.82
2DMD-EFLGEDMD-EF-01-101

2008-05-01

14.114YEARSMASIAN

2022-06-13

2022-06-13

Drug AYY115300.95
3DMD-EFLGEDMD-EF-01-1012003-07-1019.019YEARSMNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

2022-07-15

2022-07-15

Drug BYN140451.30
4DMD-EFLGEDMD-EF-01-1011999-01-1523.723YEARSMWHITE

2022-09-06

2022-09-06

2023-11-23

YDrug BYY132421.21

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.).

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-8

Categorize the value of CHG for
Definexmltable
DatasetADEFNTP
LevelVariable
PurposeAnalysis
NameVariable
Definexmltable
DatasetADCVNTP
LevelValue
PurposeAnalysis
OIDAVAL
DatasetVariableWhereTypeOriginDerivation/Comment
ADCVNTPAVALPARAMCD = "LVEFC"NumPredecessorSet to CV.CVSTRESN where CV.CVTESTCD = "LVEF_C"
ADCVNTPAVALPARAMCD = "RVEFC"NumPredecessorSet to CV.CVSTRESN where CV.CVTESTCD = "RVEF_C"
ADCVNTPAVALPARAMCD = "BNPPRONT"NumPredecessorSet to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT"
Definexmltable
DatasetADCVNTP
LevelVariable
PurposeAnalysis
NameVariable
Variable NameVariable LabelTypeCodelist/Controlled Terms/FormatSourceDerivation/Comment
STUDYIDStudy IdentifierChar

CV.STUDYID

USUBJIDUnique Subject IdentifierChar

CV.USUBJID

Select for records with RE data.ASEQAnalysis Sequence NumberNum

CV.CVSEQ

Number records 1 to n after sorting by keys.
BRTHDTDate of BirthNumDate9.

ADSL.BRTHDTC

Convert BRTHDTC from ISO 8601 format to numeric date. (Note that if exact date is not found then use two variables to capture year and month.)
TRT01P

Planned Treatment for Period 01

CharTreatment AADSL.TRT01P

ITTFL

Intent-To-Treat Population Flag

Char

Y; N

ADSL.ITTFL

BSABASEBody Surface Area (m2) at BaselineNumADSL.BSABASECompute in ADSL where VS.VSTESTCD = "BSA".

ACEINHFL

ACE Inhibitor Medications Flag

Char

Y

Select a list of ACE inhibitor medications from concomitant medications (CM) domain, and from treatment (EX or EC) domains. Code "Y" if the medication was taken during the study. Can be used to subset or to exclude the population who took ACE inhibitors.

BSABody Surface Area (m2) by VisitNum

Compute from VS.HEIGHT and VS.WEIGHT by visit, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725

Note that there are multiple methods and the study protocol should describe which one to use (e.g., Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, and Schlich).

PARAMParameterChar

Left Ventricular Ejection Fraction, Calculated (%);

Right Ventricular Ejection Fraction, Calculated (%);

N-Terminal ProB-type Natriuretic Peptide (pg/mL)

For tests from CV, set to the values of CV.CVTEST plus CV.CVTESTU with spaces and parentheses as shown. 

For tests from LB, set to the value of LB.LBTEST plus LB.LBTESTU with spaces and parentheses as shown. 

PARAMCDParameter CodeChar

LVEFC;

RVEFC;

BNPPRONT

If CV.CVTESTCD = "LVEF_C" then PARAMCD = "LVEFC"

If CV.CVTESTCD = "RVEF_C" then PARAMCD = "RVEFC"

If LB.LBTESTDC = "BNPPRONT" then PARAMCD = "BNPPRONT

Note: for this example dataset, select the records where the test values shown above are included.

PARAMNParameter (N)Num

Number PARAMCD as follows:

LVEFC = "1"

RVEFC = "2"

BNPPRONT = "3"

AVALAnalysis ValueNum

See Parameter Value List 

AVISITAnalysis VisitChar

If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)".

Else if CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)".

AVISITNAnalysis Visit (N)NumSet to value of CV.VISITNUM or LB.VISITNUMVISITVisitNum

CV.VISIT

LB.VISIT

ADTAnalysis DateNumdate9.Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9. ABLFLBaseline Record FlagCharY

If CV.VISIT = 1 then ABLFL = "Y".

BASEBaseline ValueNum

Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y".

Populate BASE for additional visits by carrying forward the value of BASE in the baseline record by USUBJID and AVISIT.

CHGChange from BaselineNumCompute CHG = AVAL - BASE for that record. Only compute for post-baseline records.PCHGPercent Change from BaselineNumCompute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records.CHGCAT1Change from Baseline Category 1Char

Decline >=10.0;

Decline < 10.0; 

Increase

Categorize the value of CHG for Left Ventricular Ejection Fraction, and Calculated (%) (LVEFC) and for Right Ventricular Ejection Fraction, Calculated (%) (RVEFC)CHGCAT2Change from Baseline Category 2Chart
Variable NameVariable LabelTypeCodelist/Controlled TermsSource/Derivation/Comment
STUDYIDStudy Identifiertext
Predecessor: CV.STUDYID
USUBJIDUnique Subject Identifiertext
Predecessor: CV.USUBJID
BRTHDTDate of Birthintegeryymmdd10.Predecessor: ADSL.BRTHDT
AAGEAnalysis Agefloat
Predecessor: ADSL.AAGE
AGEUAge Unittext

Predecessor: ADSL.AGEU

SEX

Sextext(SEX)

Predecessor: ADSL.SEX

RACE

Racetext(RACE)Predecessor: ADSL.RACE
TRTSDT

Date of First Exposure to Treatment

integeryymmdd10.Predecessor: ADSL.TRTSDT
TRT01P

Planned Treatment for Period 01

textDrug A; Drug BPredecessor: ADSL.TRT01P
TRT01A

Actual Treatment for Period 01

textDrug A; Drug BPredecessor: 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.

BSABody Surface Area (m2)float


Derived:

Compute from HEIGHT and WEIGHT at each visit, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725

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
PARAMParametertext

Left Ventricular Ejection Fraction, Cal (%);

Right Ventricular Ejection Fraction, Cal (%);

N-Terminal ProB-type Natriuretic Peptide (

pg/mL) (BNPPRONT

ng/L)

SRCDOMSource DataChar

CV; LB

Set to the SDTM domain name that relates to the analysis value.SRCSEQSource Sequence NumberNum

CV.CVSEQ

LB.LBSEQ

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

Example 1 

This example dataset shows the findings and additional analysis variables associated with:

  • Left Ventricular Ejection Fraction, Calculated (%)
  • Right Ventricular Ejection Fraction, Calculated (%)
  • N-Terminal ProB-type Natriuretic Peptide (pg/mL)

...

Nameadcvntp

...

Predecessor:

CV.CVTEST

LB.LBTEST

PARAMCDParameter Codetext

LVEF_C;

RVEF_C;

BNPPRONT

Predecessor:

CV.CVTESTCD

LB.LBTESTCD

PARAMNParameter (N)integer

1; 2; 3

Assigned:

Number PARAMCD as follows:

LVEF_C = "1"

RVEF_C = "2"

BNPPRONT = "3"

AVALAnalysis Valuefloat

See Parameter Value Metadata

AVISITAnalysis Visittext

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)".

AVISITNAnalysis Visit (N)integer1; 6

Predecessor:

CV.VISITNUM

LB.VISITNUM

VISITVisitinteger

VISIT 1; VISIT 6

Predecessor:

CV.VISIT

LB.VISIT

ADTAnalysis Dateintegeryymmdd10.Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as yymmdd10. 
ABLFLBaseline Record FlagtextY

Derived: If CV.VISIT = "VISIT 1" then ABLFL = "Y".

BASEBaseline Valuefloat

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.

CHGChange from Baselinefloat
Derived: Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records.
PCHGPercent Change from Baselinefloat
Derived: Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records.
CHGCAT1Change from Baseline Category 1text

Decline >=-5.0%; Decline <-5.0%; No Decline

See Parameter Value Metadata
SRCDOMSource Datatext

CV; LB

Assigned: Set to the SDTM domain name that relates to the analysis value.

SRCVARSource Variabletext

CVSTRESN; LBSTRESN

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

SRCSEQSource Sequence Numberinteger


Predecessor: Set to the SDTM domain sequence number that relates to the analysis value, CV.CVSEQ or LB.LBSEQ.

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. The tables below represent parameter value level lists for applicable variables.

Definexmltable
DatasetADEFNTP
Exampletrue
LevelCodelist
PurposeAnalysis
OIDPARAM.ADEFNTP
NameParameter
Permitted Value (code)

Left Ventricular Ejection Fraction, Cal (%)

Right Ventricular Ejection Fraction, Cal (%)
N-Terminal ProB-type Natriuretic Peptide (ng/L)
Definexmltable
DatasetADEFNTP
Exampletrue
LevelCodelist
PurposeAnalysis
OIDPARAMCD.ADEFNTP
NameParameter Code
Permitted Value (code)Display Value (Decode)

LVEF_C

Left Ventricular Ejection Fraction, Cal (%)

RVEF_CRight Ventricular Ejection Fraction, Cal (%)
BNPPRONTN-Terminal ProB-type Natriuretic Peptide (ng/L)
Definexmltable
DatasetADEFNTP
LevelValue
PurposeAnalysis
NameAVAL
VariableWhereTypeControlled Terms or FormatOriginDerivation/Comment
AVALCV.CVSTRESN in ("LVEF_C", "RVEF_C")float
PredecessorCV.CVSTRESN
AVALLB.LBTESTCD = "BNPPRONT"float
PredecessorLB.LBSTRESN

In this table the ADaM parameters are used rather than the source SDTM data.

Definexmltable
DatasetADEFNTP
LevelValue
PurposeAnalysis
NameCHGCAT1
VariableWhereTypeControlled Terms or FormatOriginDerivation/Comment
CHGCAT1PARAMCD in ("LVEF_C", "RVEF_C")text

Decline >=-5.0%;

Decline <-5.0%;

No Decline

Derived

Categorize the value of CHG as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=-5.0%".

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-9

Else if CHG GT 0 and CHG < 5.00 THEN CHGCAT1 = "Decline <-5.0%"

Else if CHG <0 then CHGCAT1 = "No Decline"

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-10

CHGCAT1PARAMCD = "BNPPRONT"text

Increase >100 ng/L;

Increase <=100 ng/L;

No Increase

Derived

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

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-11

Dataset wrap
Showtrue
NameADEFNTP
Dataset2
tableidadefntp
RowSTUDYIDUSUBJIDAAGEAGEUSEXRACETRT01PTRT01AITTFLHEIGHTWEIGHTBSAACEINHFLPARAMPARAMCDPARAMNAVALAVISITAVISITNVISITADTABLFLBASECHGPCHGCHGCAT1SRCDOMSRCVARSRCSEQ
1DMD-EFLGEDMD-EF-01-10112.3YEARSMBLACK OR AFRICAN AMERICANDrug ADrug AY119200.82YLeft Ventricular Ejection Fraction, Cal (%)LVEF_C167Visit 1 (Baseline)1VISIT 12022-05-16Y67


CVCVTESTCD
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-13
3
2DMD-EFLGEDMD-EF-01-10112.3YEARSMBLACK OR AFRICAN AMERICANDrug ADrug AY119200.82YRight Ventricular Ejection Fraction, Cal (%)RVEF_C274Visit 1 (Baseline)1VISIT 12022-05-16Y74


CVCVTESTCD7
3DMD-EFLGEDMD-EF-01-10112.3YEARSMBLACK OR AFRICAN AMERICANDrug ADrug AY119200.82YN-Terminal ProB-type Natriuretic Peptide (ng/L)BNPPRONT340Visit 1 (Baseline)1VISIT 12022-05-16Y40


LBLBTESTCD1
4DMD-EFLGEDMD-EF-01-10112.3YEARSMBLACK OR AFRICAN AMERICANDrug ADrug AY132321.08YLeft Ventricular Ejection Fraction, Cal (%)LVEF_C160Visit 6 (1 Year)6VISIT 62023-04-23
67-7-10.447761Decline >=-5.0%CVCVTESTCD11
5DMD-EFLGEDMD-EF-01-10112.3YEARSMBLACK OR AFRICAN AMERICANDrug ADrug AY132321.08YRight Ventricular Ejection Fraction, Cal (%)RVEF_C261Visit 6 (1 Year)6VISIT 62023-04-23
74-13-17.567568Decline >=-5.0%CVCVTESTCD15
6DMD-EFLGEDMD-EF-01-10112.3YEARSMBLACK OR AFRICAN AMERICANDrug ADrug AY132321.08Y

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

BNPPRONT3900Visit 6 (1 Year)6VISIT 62023-04-23
408602,150Increase >100 ng/LLBLBTESTCD2

ADEFMRI

The ADEFMRI is an efficacy analysis dataset with only a few records for more complex modeling of changes in ejection fraction, plus the proB-type test results. It is an ADaM Basic Data Structure (BDS) dataset

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-15
, with additional variables added from ADEFNTP dataset.

The dataset can can be used for analyses with multiple covariates

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTAUGDMDCIS-14
by taking the lab tests of interest (PARAMCD = "BNPPRONT") or other analysis datasets, and merging variables of interest with the ADEFNTP dataset. This summary dataset is created from other ADaM datasets and only variables used in the analysis are kept.

Definexmltable
DatasetADEFMRI
LevelVariable
PurposeAnalysis
NameVariable
Variable NameVariable LabelTypeCodelist/Controlled TermsSource/Derivation/Comment
STUDYIDStudy Identifiertext

Predecessor: ADEFNTP.STUDYID

USUBJIDUnique Subject Identifiertext

Predecessor: ADEFNTP.USUBJID

BRTHDTDate of Birthintegeryymmdd10.

Predecessor: ADEFNTP.BRTHDT

AAGEAnalysis Agefloat

Predecessor: ADEFNTP.AAGE

AGEUAge UnittextYEARS

Predecessor: ADEFNTP.AGEU

SEX

Sextext(SEX)

Predecessor: ADEFNTP.SEX

RACE

Racetext(RACE)

Predecessor: ADEFNTP.RACE

TRTSDT

Date of First Exposure to Treatment

Numyymmdd10.Predecessor: ADEFNTP.TRTSDT
TRT01P

Planned Treatment for Period 01

textDrug A; Drug BPredecessor: ADEFNTP.TRT01P

ITTFL

Intent-To-Treat Population Flag

text

Y; N

Predecessor: ADEFNTP.ITTFL

BSABody 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.

PARAMParametertext

Left Ventricular Ejection Fraction, Cal (%);

Right Ventricular Ejection Fraction, Cal (%)

Predecessor: ADEFNTP.PARAM

PARAMCDParameter Codetext

LVEF_C;

RVEF_C

Predecessor: ADEFNTP.PARAMCD

PARAMNParameter (N)integer


Predecessor: ADEFNTP.PARAMN

AVALAnalysis Valuefloat

Predecessor: ADEFNTP.AVAL

AVISITAnalysis Visittext

Visit 1 (Baseline);

Visit 6 (1 Year)

Predecessor: ADEFNTP.AVISIT

AVISITNAnalysis Visit (N)integer1; 6

Predecessor: ADEFNTP.AVISITN

ADTAnalysis Datefloatyymmdd10.Predecessor: ADEFNTP.ADT
ABLFLBaseline Record FlagtextYPredecessor: ADEFNTP.ABLFL
BASEBaseline Valuefloat
Predecessor: ADEFNTP.BASE
CHGChange from Baselinefloat
Predecessor: ADEFNTP.CHG
PCHGPercent Change from Baselinefloat
Predecessor: ADEFNTP.PCHG
CHGCAT1Change from Baseline Category 1text

Decline >=5.0%;

Decline <-5.0%;

Increase >100 ng/L

Predecessor: ADEFNTP.CHGCAT1
Dataset wrap
Showtrue
Nameadefmri
Dataset2
tableidadefmri
RowSTUDYIDUSUBJIDBRTHDTTRT01PAAGEAGUSEXRACETRT01AITTFLBSAACEINHFLBNPPRONTPARAMPARAMCDPARAMNAVALAVISITAVISITNADTABLFLBASECHGPCHGCHGCAT1
1DMD-EFLGEDMD-EF-01-1012010-02-07Drug A12.3YEARSMBLACK OR AFRICAN AMERICANDrug AY0.82Y40Left Ventricular Ejection Fraction, Cal (%)LVEF_C170Visit 1 (Baseline)12022-05-16Y70


2DMD-EFLGEDMD-EF-01-1012010-02-07Drug A12.3YEARSMBLACK OR AFRICAN AMERICANDrug AY0.82Y40Right Ventricular Ejection Fraction, Cal (%)RVEF_C275Visit 1 (Baseline)12022-05-16Y75


3DMD-EFLGEDMD-EF-01-1012010-02-07Drug A12.3YEARSMBLACK OR AFRICAN AMERICANDrug AY1.08Y900Left Ventricular Ejection Fraction, Cal (%)LVEF_C165Visit 6 (1 Year)62023-04-23
70-5-10.447761Decline >==5.0%
4DMD-EFLGEDMD-EF-01-1012010-02-07Drug A12.3YEARSMBLACK OR AFRICAN AMERICANDrug AY1.08Y900Right Ventricular Ejection Fraction, Cal (%)RVEF_C270Visit 6 (1 Year)62023-04-23
75-5-17.567568Decline >==5.0%

...

tableidadcvntp

...

Example 2

The dataset above can also be set up to provide multivariate analyses by taking the lab tests of interest, transposing and merging with the ADCVNTP dataset. In that case, the records from LB are not needed as a row.

...

DatasetADCVCMR
LevelValue
PurposeAnalysis
OIDAVAL

...

Nameadcvcmr

...

tableidadcvcmr

...

Example Analysis Results Metadata (ARM) Tables

For more details on ARM, see the ADaMIG and the Analysis Results Metadata (ARM) v1.0 for Define-XML v2.0 (https://www.cdisc.org/standards/foundational/adam).

Table 1. A simple comparison of change by treatment groups over one year.

...

Display

...

Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Over 1 Year

...

Data References

(incl. selection criteria)

...

PARAMCD = "LVEFC"

Where ITTFL = "Y" and AVISITN = 6;

...

Comparison of Means with 95% confidence interval

...

Programming Statements 

(Add programming language statements here: SAS, R, etc.)

...

/* Subset the data */

DATA ONE;

SET ADCVCMR;

Where ITTFL = "Y" and AVISITN = 2;

RUN;

PROC MEANS DATA=ONE MEAN STD MEDIAN ;

CLASS TRT01P;

VAR LVEF;  /*  Could add RVEF here as well */

RUN;

Table 2. This table demonstrates a model over multiple time points, adding some of the covariates that were retained in the analysis dataset.

...

Display

...

Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Over Time (Yearly)

...

Data References

(incl. selection criteria)

...

PARAMCD = "LVEFC"

Where ITTFL = "Y"

...

 The mixed model using lsmeans to compare treatment groups

...

Programming Statements 

(Add programming language statements here: SAS, R, etc.)

/* Note that PCHG is only computed post-baseline, so subset for the yearly visits, i.e. 6, 12, 18 etc. */

DATA TWO;

SET ADCVCMR;

IF PARAMCD = "LVEFC"; /* Subset by param, as there are two parameters with CHG calculated*/

Where ITTFL = "Y" and AVISITN = 2;

RUN;

PROC MIXED DATA=ADCVNTP;

CLASS STUYDID TRT01P AVISITN;

MODEL PCHG=AVISITN*TRT01P/Solution;

RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN;

LSMEANS TRT01P*AVISITN/ CL PDIFF;

RUN;

Table 3.  This example uses the dataset ADCVNTP, selecting for the parameter "N-Terminal ProB-type Natriuretic Peptide (IU/L)".

...

Display

...

Table 14.xx.xx Percent change in NTproBNP over 1 Year

...

Data References

(incl. selection criteria)

...

PARAMCD = "BNPPRONT"

Where ITTFL = "Y" AND AVISIT GE 6;

...

 The mixed model using lsmeans to compare treatment groups

...

Programming Statements 

(Add programming language statements here: SAS, R, etc.)

PROC MEANS DATA=ADCVCMR MEAN STD MEDIAN maxdec=3;

CLASS TRT01P;

BY VISIT;

VAR BNPPRONT;  

...

Pagenav2