Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

This is an example of an ADCM dataset and is based primarily on input from the SDTM CM dataset. Other adminstrative administrative data about the subjects are based on the ADSL datset dataset provided in Section 3.3.6.  > add the link. 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.     1, Subject-level Analysis Dataset (ADSL).

Example

Include Page
SDTM Example

...

.ADCM Concomitant Medications
SDTM Example

...

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.   

...

NameADCM

...

STUDYID

...

Y

...

LevelDataset
PurposeAnalysis
NameADCM

...

DatasetADCM
LevelVariable
PurposeAnalysis

...

Variable Name

...

integer

...

numeric SAS date variable based on CMSTDTC with no imputation for partial dates

...

.ADCM Concomitant Medications

Include Page
ADaM Example.ADCM Concomitant Medication
ADaM Example.ADCM Concomitant Medication

Pagenav

...

sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record

...

Pre-treatment Flag

...