myCSG © |Area: ADaM| Concept: C1008 : Record level treatment variables | Lesson: L101 : Actual Treatment in Adverse Events dataset in a 3 period crossover study |

  • In studies where the same subject takes different treatments over different periods, the treatments taken in each period will be captured in ADSL
  • We will have the start and end dates of each period reported in ADSL
  • For event start dates or collection dates in other domains, we would be interested in knowing what was the treatment that the subject was on when event started or collection was made
  • For this purpose, we have record level treament variables - TRTP(for planned treatment) and TRTA (for actual treatment)
  • We compare the event start/collection date with the period start and end dates and populate the associated treatment based on the period in which the date is falling 

 

Period 1 Period 2 Period 3
Drug A Drug B Drug C

 

Event start/collection Treatment
In period 1 Drug A
In period 2 Drug B
In period 3 Drug C
After period 3  
 

 

VARIABLE_NAMEVARIABLE_LABELDERIVATION
ASTDT Analysis Start Date Convert AESTDTC to numeric format
APERIOD Analysis Period Set to 1 when ADSL.AP01SDT <= AE.ASTDT<=ADSL.AP01EDT.
Set to 2 when ADSL.AP02SDT <= AE.ASTDT<=ADSL.AP02EDT.
Set to 3 when ADSL.AP03SDT <= AE.ASTDT<=ADSL.AP03EDT.
TRTP Planned Treatment Set to TRT01P when APERIOD=1.
Set to TRT02P when APERIOD=2.
Set to TRT03P when APERIOD=3.
TRTA Actual Treatment Set to TRT01A when APERIOD=1.
Set to TRT02A when APERIOD=2.
Set to TRT03A when APERIOD=3.
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