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- Percent change in ejection fraction over time (1 year)
- Decline in ejection fraction over time (1 year) grouped by a decline greater than 5%-5.0%
- Percent change in NT-proBNP over time (1 year)
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The SDTM examples used as the source data are from Section 2.1, Basic Systolic Function. 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.
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| Definexmltable |
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| Multiple | true |
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| Level | Dataset |
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| Purpose | Analysis |
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Dataset Name | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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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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| Definexmltable |
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| Dataset | ADEFNTP |
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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 |
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| 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 |
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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%-5.0%; Decline <5%<-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. |
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| Definexmltable |
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| Dataset | ADEFNTP |
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| Level | Value |
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| Purpose | Analysis |
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| Name | CHGCAT1 |
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| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
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| CHGCAT1 | PARAMCD in ("LVEF_C", "RVEF_C") | text | Decline >=5%-5.0%; Decline <5%<-5.0%; No Decline | Derived | Categorize the value of CHG as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=5%-5.0%". | 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-9 |
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Else if CHG GT 0 and CHG < 5.00 THEN CHGCAT1 = "Decline <5%<-5.0%" Else if CHG <0 then CHGCAT1 = "No Decline" | 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-10 |
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| | 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 |
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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-11 |
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| Dataset wrap |
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| Dataset2 |
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| | 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 |
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| 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 |
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| CV | CVTESTCD| 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-13 |
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|
| 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 |
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| 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 |
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| 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 |
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...
The dataset can can be used for multivariate 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 |
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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 |
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| 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<-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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