myCSG © |Area: SDTM| Concept: CE : Clinical Events | Lesson: LGE01 : CE - Gastroenteritis |

 

Background
  • In clinical trials, when taking a drug or investigational product, the trial participant (subject) may experience some medical occurrences along with the intended effect of the drug.
  • Some of these medical occurrences could be untoward or unintended and we call those untoward events as 'adverse events'. 
  • Some of the medical occurrences could be of specific interest within the context of a study and such occurrences which cannot be classed as 'adverse events' are called 'clinical events'
  • The occurrences which cannot be classed as 'adverse events' will be specified in the study protocol
  • Some examples of medical occurrences which could be classed as 'clinical events'
    • Decreased blood glucose levels (hypoglycemia) in a study examining the treatment of controlling blood glucose in the treatment of diabetes
    • Headache in a study examining new treatment options for migraine
    • Seizures in an epilepsy study
    • Fever in a vaccine study
    • Pain at the site of injection in an injectible vaccine study
  • In most cases, we collect information on whether specific event of interest occurred or not, and additional information when it occurred
  • The additional information collected about the event will be reported in FA domain.

What type of information is typically collected or presented?
  • Term described by the subject to explain the event
  • Standardized term for the event
  • Did the event occur?
    • No
    • Yes
      •  Start date/time of the event
      • Status of the event - ongoing or ended?
        • If ended, end date/time of the event
    • Information not collected
      • Reason for non-collection
  • Severity/intensity of the event
 
  • Complete Key programming for a clinical events dataset:
    • This code is based on a vaccine study in which Diarrhea and Vomiting are events of interest
    • Occurrence of a prespecified number of diarrhea and/or vomiting episodes in a 24-hour interval is considered as the beginning of a 'gastroenteritis event'
    • The occurrence of diarrhea and vomiting are tracked at the onset of a gastroenteritis event
    • These are tracked in three 8-hour intervals on each day
    • The occurrences are grouped based on the onset of gastroenteritis event
    • As these are prespecified events, we use CEPRESP and CEOCCUR combination to represent information in CE domain

CEEVENT : Gastroenteritis Event Symptoms
Question Response
Start Date of the Event
[CEDAT_RAW]
Nominal day of assessment for this event
[GEDAY]
Date of assessment
[GEDAT_RAW]
Any Diarrhea episodes from 00:01 to 08:00?
[DIAOCCUR_1]

Yes
No
If Yes, Number of diarrhea episodes from 00:01 to 08:00?
[DIANUM_1]
Any Diarrhea episodes from 08:01 to 16:00?
[DIAOCCUR_2]

Yes
No
If Yes, Number of diarrhea episodes from 08:01 to 16:00?
[DIANUM_2]
Any Diarrhea episodes from 16:01 to 24:00?
[DIAOCCUR_3]

Yes
No
If Yes, Number of diarrhea episodes from 16:01 to 24:00?
[DIANUM_3]
Any vomiting episodes from 00:01 to 08:00?
[VOMOCCUR_1]

Yes
No
If Yes, Number of vomiting episodes from 00:01 to 08:00?
[VOMNUM_1]
Any vomiting episodes from 08:01 to 16:00?
[VOMOCCUR_2]

Yes
No
If Yes, Number of vomiting episodes from 08:01 to 16:00?
[VOMNUM_2]
Any vomiting episodes from 16:01 to 24:00?
[VOMOCCUR_3]

Yes
No
If Yes, Number of vomiting episodes from 16:01 to 24:00?
[VOMNUM_3]
Body Temperature (degree celsius)
[TEMP]




CEDETAILS : Event Details
Question Response
Start Date of the Event
[CEDAT_RAW]
Did this event require healthcare provided visit?
[HCARE]

Yes
No
If yes, healthcare visit type
[HCARE_TYPE]

Outpatient
Emergency Room
Required oral rehydration?
[OREHYD]

Yes
No
Required intravenous hydration?
[IVREHYD]

Yes
No
Did this event result in hospitalization of subject?
[HOSP]

Yes
No



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_CEEVENTS
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'FA'
_ USUBJID Unique Subject Identifier Char Populate using SUBJECT variable
_ CESEQ Sequence Number Num Sort the records by USUBJID, CEGRPID, CETERM, CEDTC, CEEVINTX and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject
_ CEGRPID Group ID Char Populate using CEDAT_RAW after converting to ISO8601 format
_ CESPID Sponsor-Defined Identifier Char Populate using GEDAY
_ CETERM Reported Term for the Clinical Event Char 1) Create a record to populate CEOCCUR using DIAOCCUR_1 with CETERM=Diarrhea, CEEVINTX=Episodes from 00:01 to 08:00
2) Create a record to populate CEOCCUR using DIAOCCUR_2 with CETERM=Diarrhea, CEEVINTX=Episodes from 08:01 to 16:00
3) Create a record to populate CEOCCUR using DIAOCCUR_3 with CETERM=Diarrhea, CEEVINTX=Episodes from 00:01 to 08:00

Repeat the same process for VOMOCCUR_1, VOMOCCUR_2, VOMOCCUR_3, and use CETERM=Vomiting.
_ CEDECOD Dictionary-Derived Term Char Populate with the values from CETERM.
_ CECAT Category for the Clinical Event Char Populate as 'Gastroenteritis'
_ CEPRESP Clinical Event Pre-specified Char Populate as "Y".
_ CEOCCUR Clinical Event Occurrence Char See CETERM variable for details.
_ CEDTC Date/Time of Event Collection Char Populate using GEDAT_RAW.
_ CEEVINTX Evaluation Interval Text Char See CETERM variable for details.
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