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Below is the table of analysis datasets and unique parameters created for the example. The ADSL is required as part of the process of creating the subsequent analysis datasets.
The ADSL includes demographics, treatment groups, study dates and stratification variables. For this example, the ADSL is not shown other than as a source for standard ADaM variables. See Section 2.3.1 of the ADaMIG v1.3 for additional information.
ADCVEF is a dataset capturing only the tests required for this analysis, selecting for CVTESTCD equal to "LVEF_C" or "RVEF_C". The relationship dataset RELREC shows the datset relationships. There is a many to one relationship between the tests from CV and the laboratory data collected at the same visits. Therefore by subsetting the LB with LBLNKID not missing, this selects the laboratory data that can be merged with CV by USUBJID and VISIT (or USUBJID and AVISIT in ADaM) In ADaM analysis datasets we can also use a windowing strategy to select the laboratory draw closest to that visit to merge with CV which is computed in AVISIT in which case all LB records would be kept for the tests of interest.
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| Definexmltable |
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| Dataset | ADCV |
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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 |
| CV.CVSEQ | Number records 1 to n after sorting by keys. | | TRT01P | Planned Treatment for Period 01 | Char | "Treatment A" | ADSL.TRT01P | For this example we are putting "Treatment A". In a Real World Evidence study this could be non-treatment related, e.g. "Group A". | ITTFL | Intent-to-Treat | COMPLFL | Completers Population Flag | Char | Y; N | ADSL.COMPLFLITTFL | Pick other population? for RWE this does not applyPOSSIBLE RWE STUDY | | AGE | Age | Num |
| ADSL.AGE |
| | AGEU | Age Units | Char | (AGEU) | ADSL.AGEU |
| | SEX | Sex | Char | (SEX) | ADSL.SEX |
| | BSABASE | Body Surface Area at Baseline (m2) at Baseline | Num |
| ADSL.BSABSE | Compute in ADSL where VS.VSTESTCD = "BSA". | | PARAM | Parameter | Char | 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. | | 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.LBTESTDC = "BNPPRONT" then PARAMCD = "BNPPRONT. Note: for this example dataset, select the records where the test values shown above are included. | | AVAL | Analysis Value | Num |
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| See Parameter Value List | | AVISIT | Analysis Visit | Char |
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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)". | | AVISITN | Analysis Visit (N) | Num | 1, 6 |
| Set to value of CV.VISITNUM or LB.VISITNUM | | ADT | Analysis Date | Num | date9. |
| Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9. | | ABLFL | Baseline Record Flag | Char | Y |
| If CV.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". Populate BASE for additional visit by merging by USUJID and ADT. (Or by AVISIT if ADT varies for labs, and windowing is applied to select record closest to the visit) | | 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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| Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records. | | CHGCAT1 | Change from Baseline Category 1 |
| >1.0 g/dL; <=1.0 g/dL |
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| | SRCDOM | Source Data | Char | CVLB; LB |
| Set to the SDTM domain name that relates to the analysis value. | | LBSTRNRLO |
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| | LBSTRNHI |
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| | LBNRIND |
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| | 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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