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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 | 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
This is a simplified example ADSL dataset; it is expected that additional variables for stratification or of interest for analysis would be included.
| 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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shown below is an abbreviated specification of ADSL for the example. As mentioned, only a few of the required variables are shown. | Variable Name | Variable Label | Type | Codelist/Controlled Terms/Format | Source | Derivation/Comment |
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| STUDYID | Study Identifier | Char |
| DM.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
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| | 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 Exposure 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 | Derive the intent-to-treat population as per the protocol and SAP. | | BSABASE | Body Surface Area (m2) at Baseline | Num |
| ADSL.BSABASE | Set to VS.VSSTRESN in ADSL where VS.VSTESTCD = "BSA" and selecting select 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. |
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Example Analysis Results Metadata (ARM) Tables
For more details on ARM, see the ADaMIG and the Analysis Results Metadata (ARM) v1.0 for Define-XML v2.0 (https://www.cdisc.org/standards/foundational/adam).
Table 1
Display | Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Over Time |
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| Analysis Result | Comparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time (quarterly or yearly) |
| Analysis Variables(s) | PCHG |
| Analysis Reason | Primary efficacy endpoint as prespecified in the SAP |
| Analysis Purpose | Primary outcome measure |
Data References (incl. selection criteria) | PARAMCD = "LVEFC" Where ITTFL = "Y" |
| Documentation | The mixed model using lsmeans to compare treatment groups |
Programming Statements (Add programming language statements here: SAS, R, etc.) | PROC MIXED DATA=ADCVCMR; 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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