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
| Info |
|---|
Questions: - Is screening considered visit 1, or is it to include the subject into the study? SDTM team agreed to change to VISIT 1 instead of SCREENING.
- Are these Real World Evidence (RWE) studies only or clinical trials?
- Should both endpoints be shown in one efficacy dataset or two? I will be showing 3 datasets.
- What is a good surface area to use for the child subject?
- Should i use Male and 6 years? please advise.
|
This example illustrates example analysis datasets for the following endpoints:
- From CV domain
- Percent change in ejection fraction over time
Decline in ejection fraction over a time period (yearly) grouped by a decline greater than 10-5.0%.From the LB domain- Percent change in NTproBNP over a period of NT-proBNP over time (yearly1 year).
Source Data
The SDTM examples used as the source data are from Section 2.1, Basic CMR tests - Systolic Function. The example datasets show visits 1 and 6 for one subject. The subject was enrolled in the study on 20-May-2021 and the study visits were every two months. Visit 1 represents the visit at day 1 of the study, and visit 6 represents the visit at month 12 of the study. The associated laboratory test, N-Terminal ProB-type Natriuretic Peptide, is used in conjunction with ejection fraction as a biomarker and is important for diagnosis and treatment. It is also used separately to identify the percent change over a period of time.
Analysis Datasets
The example analysis dataset includes treatment and demographic information drawn from the ADSL, defined in the Metadata Table below. In this example, only some of the required variables, plus important stratification variables from ADSL, are shown. One variable mentioned body surface area (BSA), can be computed and added to ADSL. However, since the subjects are children, the body surface area changes over time. Therefore, it would probably be better to have a separate dataset to represent this over time.
The table below shows the example analysis datasets and unique parameters for this example. The Subject Level Analysis Dataset (ADSL) is a necessary component in the creation process of subsequent analysis datasets for human trials. The ADSL incorporates demographics, treatment groups, study dates, and stratification variables. In this example, the ADSL is not illustrated, but serves as a source for standard ADaM variables. Additional information can be found in Section 2.3.1 of the ADaM Implementation Guide (ADaMIG) v1.3.
The ADCVEF dataset includes tests pertinent to this analysis, those for which CVTESTCD is equal to "LVEF_C" or "RVEF_C". The relationship dataset RELREC illustrates the relationship between datasets.
The ADCVNTRP dataset is a subset of the Laboratory Results (LB) SDTM dataset, for which LBTESTCD is equal to "BNPPRONT". 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.
ADCMRI 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 ADCVEF.
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| Multiple | true |
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| Level | Dataset |
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| Purpose | Analysis |
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...
Dataset Name
...
Dataset Description
...
Structure
...
Location
...
Keys
...
ADSL
...
Subject-Level Analysis Dataset
...
BASIC DATA STRUCTURE
...
...
| Dataset | ADCVNTP |
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| Level | Value |
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| Purpose | Analysis |
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| OID | AVAL |
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...
Analysis Datasets
The subsequent section provides the data structures for the example ADaM datasets. 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), was added from ADSL.
...
| Dataset | ADCVNTP |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | Variable |
|---|
...
CV.STUDYID
...
...
CV.CVSEQ
...
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.
The records in the CV dataset for which CVTESTCD = "LVEF_C" and "RVEF_C" were selected for analysis. The records in the LB dataset where LBTESTCD = "BNPPRONT" were used to compute the percent change over time and as a potential covariate. 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 show the analysis dataset metadata and parameters used for this example.
-
| Definexmltable |
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| Multiple | true |
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| Level | Dataset |
|---|
| Purpose | Analysis |
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|
Dataset Name | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|
ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject. | Analysis | USUBJID | adsl.xpt | ADSL.SAS | | ADEFNTP | CV MRI EF and NT-proBNP Analysis | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | Analysis | USUBJID, AVISITN, PARAMN | adefntp.xpt | | | ADEFMRI | CV MRI Ejection Fraction Analysis | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | Analysis | USUBJID, AVISITN, PARAMN | adefmri.xpt | |
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ADSL
The ADSL contains subject characteristics and covariates that are important for analyses. Stratification variables can be created in the ADSL to subset 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.
| Definexmltable |
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| Dataset | ADSL |
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| Level | Variable |
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| Purpose | Analysis |
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| Name | Variable |
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|
| 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 | yymmdd10. | Derived: Date portion of DM.BRTHDTC converted to numeric and displayed in a format, such as yymmdd10. | | 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 | yymmdd10. | Derived: Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as yymmdd10. | | RFICDT | | integer | yymmdd10. | Derived: Date portion of DM.RFICDTC converted to numeric and displayed in a format such as yymmdd10. | | DTHDT | | integer | yymmdd10. | Derived: Date portion of DM.DTHDT converted to numeric and displayed in a format such as yymmdd10. | | DTHFL | | 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 × 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. |
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| Dataset wrap |
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| Dataset2 |
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| | 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 | 2010-02-07 | 12.3 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | 2022-06-16 | 2022-06-16 |
|
| Drug A | Y | Y | 119 | 20 | 0.82 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 2008-05-01 | 14.1 | 14 | YEARS | M | ASIAN | 2022-06-13 | 2022-06-13 |
|
| Drug A | Y | Y | 115 | 30 | 0.95 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 2003-07-10 | 19.0 | 19 | YEARS | M | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | | 2022-07-15 |
|
| Drug B | Y | N | 140 | 45 | 1.30 | | 4 | DMD-EFLGE | DMD-EF-01-101 | 1999-01-15 | 23.7 | 23 | YEARS | M | WHITE | 2022-09-06 | 2022-09-06 | 2023-11-23 | Y | Drug B | Y | Y | 132 | 42 | 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.).
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-8 |
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| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
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| 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 | yymmdd10. | Predecessor: ADSL.BRTHDT | | AAGE | Analysis Age | float |
| Predecessor: ADSL.AAGE | | AGEU | Age Unit | text |
|
Predecessor: ADSL.AGEU | SEX | Sex | text | (SEX) | | RACE | Race | text | (RACE) | Predecessor: ADSL.RACE | | TRTSDT | Date of First Exposure to Treatment | integer | yymmdd10. | 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 | | 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 × 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 | | 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 | yymmdd10. | Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as yymmdd10. | | 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 >=-5.0%; Decline <-5.0%; 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. |
|
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 |
|---|
| Dataset | ADEFNTP |
|---|
| Example | true |
|---|
| Level | Codelist |
|---|
| Purpose | Analysis |
|---|
| OID | PARAM.ADEFNTP |
|---|
| Name | Parameter |
|---|
|
| Permitted Value (code) |
|---|
Left Ventricular Ejection Fraction, Cal (%) | | Right Ventricular Ejection Fraction, Cal (%) | | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
|
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Example | true |
|---|
| Level | Codelist |
|---|
| Purpose | Analysis |
|---|
| OID | PARAMCD.ADEFNTP |
|---|
| Name | Parameter Code |
|---|
|
| Permitted Value (code) | Display Value (Decode) |
|---|
LVEF_C | Left Ventricular Ejection Fraction, Cal (%) | | RVEF_C | Right Ventricular Ejection Fraction, Cal (%) | | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
|
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Level | Value |
|---|
| Purpose | Analysis |
|---|
| Name | AVAL |
|---|
|
| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
|---|
| AVAL | CV.CVSTRESN in ("LVEF_C", "RVEF_C") | float |
| Predecessor | CV.CVSTRESN | | AVAL | LB.LBTESTCD = "BNPPRONT" | float |
| Predecessor | LB.LBSTRESN |
|
In this table the ADaM parameters are used rather than the source SDTM data.
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Level | Value |
|---|
| Purpose | Analysis |
|---|
| Name | CHGCAT1 |
|---|
|
| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
|---|
| CHGCAT1 | PARAMCD 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 |
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| 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 <-5.0%" Else if CHG <0 then CHGCAT1 = "No Decline" | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-10 |
|---|
|
| | CHGCAT1 | PARAMCD = "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 |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-11 |
|---|
|
|
|
| Dataset wrap |
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|
| Dataset2 |
|---|
| | 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 | Drug A | Y | 119 | 20 | 0.82 | Y | Left Ventricular Ejection Fraction, Cal (%) | LVEF_C | 1 | 67 | Visit 1 (Baseline) | 1 | VISIT 1 | 2022-05-16 | Y | 67 |
|
|
| CV | CVTESTCD| Jira |
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| showSummary | false |
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| 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 | Drug A | Y | 119 | 20 | 0.82 | Y | Right Ventricular Ejection Fraction, Cal (%) | RVEF_C | 2 | 74 | Visit 1 (Baseline) | 1 | VISIT 1 | 2022-05-16 | Y | 74 |
|
|
| CV | CVTESTCD | 7 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | 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 | 2022-05-16 | Y | 40 |
|
|
| LB | LBTESTCD | 1 | | 4 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | Left Ventricular Ejection Fraction, Cal (%) | LVEF_C | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 | 2023-04-23 |
| 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 | Drug A | Y | 132 | 32 | 1.08 | Y | Right Ventricular Ejection Fraction, Cal (%) | RVEF_C | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 | 2023-04-23 |
| 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 | 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 | 2023-04-23 |
| 40 | 860 | 2,150 | Increase >100 ng/L | LB | LBTESTCD | 2 |
|
|
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 |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-15 |
|---|
|
, with additional variables added from ADEFNTP dataset.
The dataset can can be used for analyses with multiple covariates
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-14 |
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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 |
|---|
| 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 | yymmdd10. | 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 | yymmdd10. | 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 | yymmdd10. | 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 |
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| Dataset wrap |
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| Dataset2 |
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| | 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 |
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| 1 | DMD-EFLGE | DMD-EF-01-101 | 2010-02-07 | 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) | 1 | 2022-05-16 | Y | 70 |
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| | 2 | DMD-EFLGE | DMD-EF-01-101 | 2010-02-07 | 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) | 1 | 2022-05-16 | Y | 75 |
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| | 3 | DMD-EFLGE | DMD-EF-01-101 | 2010-02-07 | 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) | 6 | 2023-04-23 |
| 70 | -5 | -10.447761 | Decline >==5.0% | | 4 | DMD-EFLGE | DMD-EF-01-101 | 2010-02-07 | 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) | 6 | 2023-04-23 |
| 75 | -5 | -17.567568 | Decline >==5.0% |
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LVEFC;
RVEFC;
BNPPRONT;
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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.
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Number PARAMCD as follows:
LVEFC = "1"
RVEFC = "2"
BNPPRONT = "3"
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See Parameter Value List
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If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)".
Else if CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)".
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CV.VISIT
LB.VISIT
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If CV.VISIT = 1 then ABLFL = "Y".
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Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y".
Populate BASE for additional visits by copying the value of BASE in the baseline record by USUBJID and ADT. (Or by AVISIT if ADT varies for labs, where windowing is applied to select record closest to the visit)
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Decline >=10.0;
Decline < 10.0;
Increase
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Planned Treatment for Period 01
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ITTFL
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Intent-to-Treat Population Flag
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Char
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Y; N
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ADSL.ITTFL
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CV; LB
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CV.CVSEQ
LB.LBSEQ
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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)
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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 ADCVNTPP dataset. In that case, the records from LB are not needed as a row.
The variables transposed and merged to the rows created from CV are:
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Example Analysis Results Metadata (ARM) Tables
This table may be included in the submission package for regulatory agencies. It describes the analyses conducted for the study (usually limited to primary and secondary endpoints) with details on data and analysis procedures used. The first example uses the dataset ADCVNTPR, selecting for the parameter "N-Terminal ProB-type Natriuretic Peptide (IU/L)".
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Display
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Table 14.xx.xx Percent change in NTproBNP over a period of time (yearly)
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Data References
(incl. selection criteria)
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PARAMCD = "BNPPRONT"
Where ITTFL = "Y"
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The mixed model using lsmeans to compare treatment groups
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Programming Statements
(Add programming language statements here: SAS, R, etc.)
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PROC MIXED DATA=ADCVNTPR;
WHERE PARAMCD = "BNPPRONT";
CLASS STUYDID TRT01P AVISITN;
MODEL PCHG=AVISITN*TRT01P/Solution;
RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN;
LSMEANS TRT01P*AVISITN/ CL PDIFF;
RUN;
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Display
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Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Over Time
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Data References
(incl. selection criteria)
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PARAMCD = "LVEFC"
Where ITTFL = "Y"
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The mixed model using lsmeans to compare treatment groups
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Programming Statements
(Add programming language statements here: SAS, R, etc.)
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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;
| Info |
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Ejection Fraction - change in ejection fraction, would expect a decline in EF 2-3% per year, would prefer an improvement or no change. Concerning if rapid progression, 10% decline or more, for example.
NTproBNP - % change over a period of time – a decrease would mean improvement, annually is appropriate
SDTM Examples: Basic CMR tests - Systolic Function |