myCSG © |Area: SDTM| Concept: AE : Adverse Events | Lesson: LCSG001 : Adverse Events Programming for study CSG001 |

 

Background

In clinical trials, when taking a drug or investigational product, the trial participant (subject) may experience some untoward medical occurrences along with the intended effect of the drug. These untoward medical occurrences are called 'Adverse events'.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether related to the medicinal (investigational) product.

What type of information is typically collected or presented?
  • Term described by the subject to explain the adverse event
  •  Start date/time of the event
  • Status of the event - ongoing or ended?
    • If ended, end date/time of the event
  • Severity of the event
  • Pattern of the event if applicable
  • Any additional medication given/taken to treat the event
  • Location and laterality of the event if applicable
  • Investigator's assessment/action of the event
    • Relationship/causality to the study drug
    • Relation to non-study treatment
    • Is the event serious?
      • If yes, specific criteria on why the event is considered serious.
        • Caused cancer
        • Caused congenital anomaly or birth defect
        • Caused Persistent or Significant Disability/Incapacity
        • Resulted in death of the subject
        • Is the event life threatening
        • Caused hospitalization or prolonged existing hospitalization
    • Action taken with the study treatment
    • Did the event occur with overdose of study medication
 

 

In this lesson, we learn the below things:

  • How to write a programming specification for this domain
  • How to interpret an existing SDTM programming specification
  • How to program as per the specification
  • How to convert raw dates to SDTM compliant ISO 8601 date values
  • How to create study day variables
  • How to derive EPOCH variable using subject elements dataset
  • How to derive --SEQ variable 
  • How to create labels for variables using attributes statement
  • How to create a supplementary domain
  • How to convert a sas dataset into xpt format using proc copy and xport engine of libname statement
variable_namevariable_labelderivation
STUDYID Study Identifier Equals to the value from raw.adverse.STUDY
DOMAIN Domain Abbreviation Assign as 'AE'
USUBJID Unique Subject Identifier Derive by concatenating raw.adverse.STUDY and raw.adverse.PT variable values, separated with a hyphen in between
AESEQ Sequence Number Sort the records by USUBJID, AEDECOD, AESTDTC and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject.

seq
AETERM Reported Term for the Adverse Event Equals to the value from raw.adverse.AEVT
AELLT Lowest Level Term Equals to the value form raw.adverse.AELLT
AEDECOD Dictionary-Derived Term Equals to the value from raw.adverse.AEDECOD
AECAT Category for Adverse Event Equals to the value from raw.adverse.AECAT
AEBODSYS Body System or Organ Class Equals to the value from raw.adverse.AEBODSYS
AESEV Severity/Intensity Equals to the value from raw.adverse.AESEV, after converting to standard controlled terminology
AESER Serious Event Equals to the value form raw.adverse.AESER, after converting to standard controlled terminology
AEACN Action Taken with Study Treatment Equals to the value from raw.adverse.AEACN, after converting to standard controlled terminology
AEACNOTH Other Action Taken Equals to the value from raw.adverse.AEACNOTH
AEREL Causality Equals to the value from raw.adverse.AEREL, after converting to standard controlled terminology
AEOUT Outcome of Adverse Event Equals to the value form raw.adverse.AEOUT, after converting to standard controlled terminology
AESCONG Congenital Anomaly or Birth Defect Equals to the value from raw..adverse.SCONG, after converting to standard controlled terminology
AESDISAB Persist or Signif Disability/Incapacity Equals to the value from raw..adverse.SDISAB, after converting to standard controlled terminology
AESDTH Results in Death Equals to the value from raw..adverse.SDEATH, after converting to standard controlled terminology
AESHOSP Requires or Prolongs Hospitalization Equals to the value from raw..adverse.SHOSP, after converting to standard controlled terminology
AESLIFE Is Life Threatening Equals to the value from raw..adverse.SLIFE, after converting to standard controlled terminology
AESMIE Other Medically Important Serious Event Equals to the value from raw..adverse.SMIE, after converting to standard controlled terminology
EPOCH Epoch Derive by comparing sdtm.ae.AESTDTC 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 event start date falls.
epoch
AESTDTC Start Date/Time of Adverse Event Equals to the value from raw.adverse.AESTDT_RAW, after converting to ISO 8601 format
AEENDTC End Date/Time of Adverse Event Equals to the value from raw.adverse.AEENDT_RAW, after converting to ISO 8601 format
AESTDY Study Day of Start of Adverse Event If the event date is on or after reference start date then sdtm.ae.AESTDTC-sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.ae.AESTDTC-sdtm.dm.RFSTDTC.
studyday
AEENDY Study Day of End of Adverse Event If the event date is on or after reference start date then sdtm.ae.AEENDTC - sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.ae.AEENDTC-sdtm.dm.RFSTDTC.
PREFDOSE Prior to First Dose? Equals to the value from raw.adverse.PREFDOSE
AETRTEM Treatment Emergent Flag Derive by using the information present in raw.adverse.PREFDOSE and comparing sdtm.ae.AESTDTC with sdtm.dm.RFSTDTC and sdtm.dm.RFXENDTC. If raw.adverse.PREFDOSE="Y" then set to "N". Else if sdtm.ae.AESTDTC is on or after sdtm.dm.RFSTDTC but before (sdtm.dm.RFXENDTC+15) then set to "Y". Else set to "N".
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