myCSG © |Area: SDTM| Concept: EX : Exposure | Lesson: LCSG001 : EX dataset Programming for study CSG001 |

Background
  • In clinical trials, we administer 'study treatments' to the subjects over time as per requirement
  • We need to report the exposure of these study drug administrations in terms of 'protocol-specified unit'
  • SDTM standard has standard data structure for reporting such data - "Exposure (EX)"

 

  • Understanding 'Protocol-specified unit'
    • Example 1: The protocol may specify that 50 mg of drug will be administered but the collection is in terms number of tablets administered. Let's say, to receive 50 mg, subject has to take two tablets of 25mg each. 
      • We report the number of tablets taken in EC domain
      • We translate the information from number of tablets and strength of the tablet to actual dose received and present in EX. If two tablets are taken then EXDOSE will be 50 mg, if only one tablet is taken then EXDOSE will be 25 mg.
    • Example 2: The protocol may specify that 100mg of drug has to be administered and the dosage form is an infusion of 100 ml. The collection here can only be made in terms of total volume of infusion administered. 
      • We report the volume administered in EC domain
      • We translate the information from volume of infusion administered and strength to actual dose received and present in EX. If 100 ml of infusion is administered, then EXDOSE is 100 mg. If only 35 ml is administered, then EXDOSE will only be 35 mg (1ml==1mg). 
    • Example 3: In some studies, where both planned dose and actual dose are collected, we use EC to present both doses. In EX, we only present the actual dose records.

 

  • EX domain falls under interventions class of the SDTM domains and has an expected record structure of 'One record per protocol-specified study treatment, constant-dosing interval'

What type of information is typically collected or presented?
  • Treatment name
  • Start date/time of the treatment
  • End date/time of the treatment
  • Dose and dosing unit of the treatment
  • Frequency of administration (once daily/twice daily etc.)
  • Route of administration (oral/intravenous/intramuscular etc.)
  • Dosage form (tablet/capsule/injection etc.)
  • Location of administration (Hand/Thigh etc.)
  • Laterality (Left/Right etc.)
  • Was the dose adjusted for any reason?
    • Reason for adjustment
  • Lot number of the treatment package

In this lesson,

  • We will see how to translate the volume of injection administered to protocol specified unit using drug concentration to create EX domain
variable_namevariable_labelderivation
General Volume of injection administered is captured in ipadmin dataset. The volume administered is captured in EC domain, and the amount of dose given (in micrograms) will be captured in EX domain.
STUDYID Study Identifier Equals to the value from raw.ipadmin.STUDY
DOMAIN Domain Abbreviation Assign as "EX"
USUBJID Unique Subject Identifier Derive by concatenating the values from raw.ipadmin.STUDY and raw.ipadmin.PT separated with a hyphen in between
EXSEQ Sequence Number Sort the records by USUBJID,EXTRT,EXSTDTC and set to 1 on the first record of the subject and increment by 1 on subsequent records within the subject
EXTRT Name of Treatment Derive by fetching raw.box.CONTENT by joining raw.ipadmin and raw.box datasets based on raw.ipadmin.IPBOXID and raw.box.KITID. If CONTENT="PBO" then assign as 'PLACEBO", else if CONTENT="ACTIVE" then assign as "ACTIVE".
EXDOSE Dose Derive by multiplying the value from raw.ipadmin.IPQTY_RAW and raw.ipadmin.IPCONC. Assign as 0 when EXTRT="PLACEBO"
EXDOSU Dose Units Assign as "ug"
EXDOSFRM Dose Form Assign as "INJECTION"
EXDOSFRQ Dosing Frequency per Interval Assign as "EVERY WEEK"
EXROUTE Route of Administration Assign as "INTRAVENOUS"
EXLOT Lot Number Derive by fetching raw.lot.LOTNUM by joining raw.ipadmin and raw.lot datasets based on raw.ipadmin.IPBOXID and raw.lot.KITID. Assign the value of LOTNUM to ECLOT.
EXADJ Reason for Dose Adjustment Equals to the value from raw.ipadmin.IPADJ after converting to upper case
EPOCH Epoch Assign as "TREATMENT"
EXSTDTC Start Date/Time of Treatment Derive the datetime value in ISO 8601 format by obtaining the information from raw.ipadmin.IPSTDT_RAW and raw.ipadmin.IPSTTM_RAW variables.
EXENDTC End Date/Time of Treatment Equals to the value from sdtm.ex.EXSTDTC
EXSTDY Study Day of Start of Treatment If the administration date is on or after reference start date then sdtm.ex.EXSTDTC-sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.ex.EXSTDTC-sdtm.dm.RFSTDTC.
EXENDY Study Day of End of Treatment If the administration date is on or after reference start date then sdtm.ex.EXENDTC - sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.ex.EXENDTC-sdtm.dm.RFSTDTC.
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