Concomitant Insulin Treatment 

The sponsor assigned "ANTIDIABETIC" to the CMCAT variable. The variable CMTRT was used to represent the type of insulin used by the subject. Although sponsors may collect actual trade names, for this example study trade names were not collected. CMDECOD is the dictionary-assigned name of the insulin. The variable CMDECOD (not shown) may be used by sponsors to represent appropriate dictionary coding terms. Although the mean total daily dose (over the previous 7 days) was collected at each visit, the sponsor chose not to represent a summarized total daily dose for the whole treatment period. The CMDOSTOT variable is therefore not included in the CM table shown here. If available, the collected dosing frequency is shown in the CMDOSFRQ variable. When a complete start date was not available, partial dates were collected and represented in the variable CMSTDTC. If no information on the start date was available, CMSTRF was used to report that the insulin started before the sponsor-defined study reference period. For insulin treatment that was ongoing at the end of the study, the CMENRF variable was used to indicate that the insulin ended after the sponsor-defined study reference period.

The FACM dataset was used to store the mean total daily dose of insulin that was recorded at each visit for ongoing insulin treatments. The values of the NSV FACOLSRT and FAEVLINT variable indicate that the result represents a mean over the 7 days prior to the assessment date, which is shown in the FADTC variable. The following table shows the first 3 records associated with each of the insulin treatments in the preceding CM table.

The RELREC dataset was used to record the relationship between the insulin treatment records in CM and the average total daily dose records in FACM.