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| Definexmltable |
|---|
| Multiple | true |
|---|
| Level | Dataset |
|---|
| Purpose | Analysis |
|---|
|
Dataset Name | Dataset Description | Class of Dataset | Structure | Location | Keys | Documentation |
|---|
ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject | adsl.xpt | USUBJID | ADaMIG | | ADCVNTP | Cardiac Ejection Fraction and NTproBNP Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter | adcvntp.xpt | USUBJID, AVISITN, PARAMN | | | ADCVCMR | Cardiovascular CMR Ejection Fraction Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter | adcvcmr.xpt | USUBJID, AVISITN, PARAMN | |
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ADSL Analysis Dataset
Below is an abbreviated specification of ADSL for the example. As mentioned, not all of the required variables are shown.
| Definexmltable |
|---|
| Dataset | ADSL |
|---|
| 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 |
|---|
| STUDYID | Study Identifier | Char |
| DM.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
| |
| | BRTHDT | Date of Birth | Num | date9. | 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.) | | TRTSDT | Date of First Exposutre to Treatment. | Num | date9. |
| Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as DATE9. | | TRT01P | Planned Treatment for Period 01 | Char | Treatment A | ADSL.TRT01P | 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 | Y; N | ADSL.ITTFL | | | BSABASE | Body Surface Area (m2) at Baseline | Num |
| ADSL.BSABASE | Set to VS.VSSTRESN in ADSL where VS.VSTESTCD = "BSA" and selecting for baseline visit. | 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. |
|
| Definexmltable |
|---|
| Dataset | ADCVNTP |
|---|
| Level | Value |
|---|
| Purpose | Analysis |
|---|
| OID | AVAL |
|---|
|
| Dataset | Variable | Where | Type | Origin | Derivation/Comment |
|---|
| ADCVNTP | AVAL | PARAMCD = "LVEFC" | Num | Predecessor | Set to CV.CVSTRESN where CV.CVTESTCD = "LVEF_C" | | ADCVNTP | AVAL | PARAMCD = "RVEFC" | Num | Predecessor | Set to CV.CVSTRESN where CV.CVTESTCD = "RVEF_C" | | ADCVNTP | AVAL | PARAMCD = "BNPPRONT" | Num | Predecessor | Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" |
|
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