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This is an example of an ADCM dataset and is based primarily on input from the SDTM CM dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x, Analysis Data Subject Level (ADSL).
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This is an example of the input SDTM CM datasets used to create the ADCM. Only variables needed for illustration are shown in the examples.
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Below is an example ADaM CM dataset amd associate metadata designed to support the summarization of concomitant medications. Included are a subset of variables that are commonly inluded to support a basic summary table - for a full list of commonly used and available variables please see Section 2.3.1.1 in the OCCDS section that references Concomitant Medications.
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| Name | ADCM |
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STUDYID
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Y
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| Dataset | ADCM |
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| Level | Variable |
| Purpose | Analysis |
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Variable Name
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integer
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numeric SAS date variable based on CMSTDTC with no imputation for partial dates
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| Pagenav |
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sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record
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Pre-treatment Flag
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