myCSG © |Area: SDTM| Concept: CM : Concomitant Medications | Lesson: LCSG001 : CM dataset Programming for study CSG001 |

Background

When participating in clinical trials, the subjects might already have been on some medications or may need to take additional medications while on study. These additional medications taken prior or alongside the study medications are termed as prior/concomitant medications.

Information on these medications to understand if there is any impact of these other medications on the safety or efficacy of study medication.

In most cases, this information is collected by asking the subjects to report any medications taken and one entry will be made for a constant dosing interval for each medication. However, there will be cases where we may specifically want to understand if the subject is taking a particular medication. We call this scenario capturing the usage of prespecified medications. For example, we may ask if the patient was exposed to any antibiotics or corticosteroids in the last three months. etc.

What type of information is typically collected or presented?
  • Medication name
  • Start date/time of the medication
  • Status of the medication - ongoing or ended?
    • If ended, end date/time of the medication
  • Dose and dosing unit of the medication
  • Frequency of administration (once daily/twice daily etc.)
  • Route of administration (oral/intravenous/intramuscular etc.)
  • Dosage form (tablet/capsule/injection etc.)
  • Indication for which the medication is taken (e.g.: paracetamol could be taken for fever or general body pain - same medication different purpose)

Test CM description.

variable_namevariable_labelderivation
General Prior and concomitant medication information is collected in conmeds dataset.
STUDYID Study Identifier Equals to the value form raw.conmeds.STUDY
DOMAIN Domain Abbreviation Assign as "CM"
USUBJID Unique Subject Identifier Derive by concatentating the value from variables raw.conmeds.STUDY and raw.conmeds.PT with hyphen in between
CMSEQ Sequence Number Sort the records by USUBJID,CMDECOD,CMSTDTC and set to 1 on the first record of each subject and increment by 1 on each subsequent record
CMTRT Reported Name of Drug, Med, or Therapy Equals to the value from raw.conmeds.CMVT
CMDECOD Standardized Medication Name Equals to the value from raw.conmeds.CMPT
CMCAT Category for Medication Equals to the value from raw.conmeds.CMCAT after converting to uppercase
CMINDC Indication Equals to the value from raw.conmeds.CMINDC
CMDOSE Dose per Administration If raw.conmeds.CMDOSE_RAW contains a numeric value then assign the numeric value to CMDOSE.
CMDOSTXT Dose Description If raw.conmeds.CMDOSE_RAW contains a non-numeric value then assign the value to CMDOSTXT.
CMDOSU Dose Units Equals to the value from raw.conmeds.CMDOSU_RAW after converting to standard controlled terminology
CMDOSFRQ Dosing Frequency per Interval Equals to the value from raw.conmeds.CMDOSFRQ after converting to standard controlled terminology
CMROUTE Route of Administration Equals to the value from raw.conmeds.ROUTE after converting to standard controlled terminology
EPOCH Epoch Derive by comparing sdtm.cm.CMSTDTC with the sdtm.se.SESTDTC and sdtm.se.SEENDTC of each element of a subject and assign the epoch based on the sdtm.se.EPOCH of the element in which each medication start date falls.
CMSTDTC Start Date/Time of Medication Equals to the value from raw.conmeds.CMSTDT_RAW, after convering to ISO 8601 format
CMENDTC End Date/Time of Medication Equals to the value from raw.conmeds.CMENDT_RAW, after converting to ISO 8601 format
CMSTDY Study Day of Start of Medication If the medication start date is on or after reference start date then sdtm.cm.CMSTDTC-sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.cm.CMSTDTC-sdtm.dm.RFSTDTC.
CMENDY Study Day of End of Medication If the medication end date is on or after reference start date then sdtm.cm.CMENDTC - sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.cm.CMENDTC-sdtm.dm.RFSTDTC.
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