myCSG © |Area: ADaM| Concept: C1003 : Treament emergence, pre and post treatment occurrences | Lesson: L102 : Adverse Event Treatment Emergence Flag - considering the baseline severity |

Background

 

USBJID

Event

Event Date

Treatment start

Pretreatment

TEAE?

 

 

 

 

Y

 

 

 

 

 

Y

 

 

 

 

 

  

Y

 

 

 

 

 

Y

 

 

 

 

 

Y

 
Treatment emergent flag
No date imputations
Baseline severity considered

Lesson description will be added soon
VARIABLE_NAMEVARIABLE_LABELDERIVATION
ASTDT Analysis Start Date Convert AESTDTC to numeric format
AENDT Analysis End Date Convert AEENDTC to numeric format
TRTEMFL Treatment Emergent Flag A. For the AEDCODs which do not exist prior to treatment start:
     Set to 'Y' on the records where ASTDT is not null and greater than or equals to TRTSDT. Else set to 'N'.
B. For the AEDECODs which exist prior to treatment start and reccur after treatment start:
     Set to 'Y' records where ASTDT is greater than or equal to treatment start date and the severity is greater than the maximum severity observed for that AEDECOD and USUBJID prior to treatment start. Else set to 'N'.
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