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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 | Dataset Description | Class of Dataset | Structure | Location | Keys | Documentation |
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ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | adsl.xpt | One record per subject | USUBJID | ADaMIG v1.3 section 3.1.1 | | ADCVEF | Cardiac Ejection Fraction Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcvef.xpt | USUBJID, AVISITN, PARAMCD | | | ADNTRPO | Cardia NTproBNP Laboratory Analyis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adntpro.xpt | USUBJID, AVISITN, PARAMCD | | | ADCMRI | Cardiac Magnetic Resonance Imaging Measurements Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | adcmri.xpt | USUBJID, AVISITN, PARAMCD | |
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ADCV Analysis Dataset
This example analysis dataset used the SDTM CV dataset for input which shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction.
CVDTC is the date of the CMR procedure, CVDY is the study. For the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every twp months.The CVLNKID variable is used to identify a record to show a relationship between records in separate domains.
The following are the parameters for the example ADaM datasets. Note that the columns for derived variables, BASE, and CHG have been added, as well as selected variables from ADSL. The rows needed from the spirometry and 6MWT for ranking change from baseline were created in the safety analysis datasets. These derived rows were then copied to ADCOMPOS. The ADCOMPOS example shows the final rows required.
| Definexmltable |
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| Dataset | ADSPIRO |
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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/Format | Source | Derivation/Comment |
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| STUDYID | Study Identifier | Char |
| CV.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
| | Select for records with RE data. | | ASEQ | Analysis Sequence Number | Num |
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| Sequence number given to ensure uniqueness of subject records within an ADaM dataset. Number the records 1 to n after sorting by the key variables.ASEQ | Analysis Sequence Number | Num | xxxxxxx | | TRT01P | Planned Treatment for Period 01 | Char |
| ADSL.TRT01P |
| COMPLFL | Completers Population Flag | Char | Y; N | ADSL.COMPLFL | | | AGE | Age | Num |
| ADSL.AGE |
| | AGEU | Age Units | Char | (AGEU) | ADSL.AGEU |
| | SEX | Sex | Char | (SEX) | ADSL.SEX |
| | PARAM | Parameter | Char | Left Ventricular Ejection Fraction, Calculated (%) Right Ventricular Ejection Fraction, Calculated (%) N-Terminal ProB-type Natriuretic Peptide (pg/mL)
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| Move to PVLM Table Set to "CV.CVTEST" plus "(CV.CVTESTU)" with spaces and parentheses as shown.
Set to "LB.LBTEST" plus "(CV.CVTESTU)" with spaces and parentheses as shown. | | PARAMCD | Parameter Code | Char | 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.LBTESTCD = "BNPPRONT" then PARAMCD = "BNPPRONT" Set to value of CV.CVTESTCD.
| | AVAL | Analysis Value | Num |
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| Set to value of CV.CVSTRESN. Set to value of LB.LBSTRESN. | | AVISIT | Analysis Visit | Char | ?????? |
| If CV.VISIT = "VSCREENINGSCREENING" then AVISIT = "XXX". Else if CV.VISIT = "VISIT 6" then AVISIT = "XXXX". | | AVISITN | Analysis Visit (N) | Num | 1, 6 |
| Set to value of CV.VISITNUM. | | VISIT | Visit | Char |
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| | ADT | Analysis Date | Num | date9. |
| Date portion of CV.CVDTC converted to numeric and displayed in a format such as date9. Date in SDTM represents date of CMR procedure. | | ABLFL | Baseline Record Flag | Char | Y |
| Check on visit numbering If VISIT = 1 then ABLFL = "Y". | | BASE | Baseline Value | Num |
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| Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". | | CHG | Change from Baseline | Num |
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| Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records. | | PCHG | Percent Change from Baseline | Num |
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| PCHG = (CHG / BASE) * 100 | | CHGCAT1 | Change from Baseline Category 1 |
| >1 g/dL; <=1 g/dL |
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| | SRCDOM | Source Data | Char | CV LB |
| Set to the SDTM domain name that relates to the analysis value. | | SRCSEQ | Source Sequence Number | Num | CV.CVSEQ LB.LBSEQ |
| Set to the SDTM domain sequence number that relates to the analysis value. |
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