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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.x3.3.6.1, Analysis Data Subject Level Subject-level Analysis Dataset (ADSL).

Example

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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SDTM Example.ADaM CMADCM Concomitant Medications
SDTM Example.ADaM CM

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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NameADCM

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STUDYID

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Y

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DatasetADCM
LevelVariable
PurposeAnalysis

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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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ADCM Concomitant Medications

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ADaM Example.ADCM Concomitant Medication
ADaM Example.ADCM Concomitant Medication

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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