Concomitant Insulin Treatment 

Illustrates Domains

CM
 FA
RELREC 

Illustrates Variables

CMROUTE
CMENRFFATEST
FATESTCD
FAOBJ


Content

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.

cm.xpt

cm.xpt

Row

STUDYID

DOMAIN

USUBJID

CMSEQ

CMSPID

CMTRT

CMCAT

CMDOSFRQ

CMROUTE

CMSTDTC

CMENDTC

CMSTDY

CMSTRFCMENRF
1TD23CM000111

Rapid-acting insulin

ANTIDIABETIC

SUBCUTANEOUS

2015-11-27
-600
AFTER
2TD23CM000311Regular insulin
ANTIDIABETIC
SUBCUTANEOUS2016-05


AFTER
3TD23CM000511Pre-mixed insulin
ANTIDIABETICTIDSUBCUTANEOUS


BEFOREAFTER
4TD23CM000522Inhaled insulinANTIDIABETICTID

RESPIRATORY (INHALATION)

2017-10-08
-365
AFTER

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.

facm.xpt

facm.xpt

RowSTUDYIDDOMAINUSUBJIDFASEQFALNKIDFATESTCDFATESTFAOBJFAORRESFAORRESUFASTRESCFASTRESNFASTRESUVISITNUMVISITFADTCFAEVLINT
FACOLSRT
1TD23FA000111DOSTOTTotal Daily DoseRapid-acting insulin40.5U40.540.5U1Baseline2017-07-19-P7D
MEAN
2TD23FA000121DOSTOTTotal Daily DoseRapid-acting insulin42.1U42.142.1U2Week 12017-07-26-P7D
MEAN
3TD23FA000131DOSTOTTotal Daily DoseRapid-acting insulin41.4U41.441.4U3Week 22017-08-02-P7D
MEAN
4TD23FA000311DOSTOTTotal Daily DoseRegular insulin46.9U46.946.9U1Baseline2018-03-12-P7D
MEAN
5TD23FA000321DOSTOTTotal Daily DoseRegular insulin43.8U43.843.8U2Week 12018-03-19-P7D
MEAN
6TD23FA000331DOSTOTTotal Daily DoseRegular insulin47.1U47.147.1U3Week 22018-03-26-P7D
MEAN
7TD23FA000511DOSTOTTotal Daily DosePre-mixed insulin45.1U45.145.1U1Baseline2018-10-08-P7D
MEAN
8TD23FA000522DOSTOTTotal Daily DoseInhaled Insulin12.4U12.412.4U1

Baseline

2018-10-08-P7D
MEAN
9TD23FA000531DOSTOTTotal Daily DosePre-mixed insulin45.1U45.145.1U2Week 12018-10-15-P7D
MEAN
10TD23FA000542DOSTOTTotal Daily DoseInhaled Insulin11.5U11.511.5U2Week 12018-10-15-P7D
MEAN
11TD23FA000551DOSTOTTotal Daily DosePre-mixed insulin46.2U46.246.2U3Week 22018-10-22-P7D
MEAN
12TD23FA000562DOSTOTTotal Daily DoseInhaled insulin11.6U11.611.6U3Week 22018-10-22-P7D
MEAN

FACM NSV Metadata

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.

relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1TD23CM
CMSPID
ONECMFA1
2TD23FACM
FALNKID
MANYCMFA1