JMP Clinical Basics | Determining If an Event Is a Treatment Emergent Adverse Event

Determining If an Event Is a Treatment Emergent Adverse Event
JMP Clinical uses the TreatmentEmergent SAS macro to determine whether records might be:
On Treatment. Those are events that begin on or after the first dose of any study drug until the last date of dosing plus the offset1 for end of dosing
This macro can be applied to event domains (including AE and CE), intervention domains (including CM) and findings domains (including VS).
Algorithm
The macro used to calculate TEAEs incorporates the following:
If either xx.xxTRTEM or xx.TRTEMFL are present with a value of either Yes or Y, the event is considered as treatment emergent.
The start dates for dosing are determined from ADSL.TRTSDTM. If ADSL.TRTSDTM is not present, ADSL.TRTSDT is used. If ADSL.TRTSDT is not present, DM.RFXSTDTC is used. If DM.RFXSTDTC is not present, the earliest date in EX.EXSTDTC is used. If EX.EXSTDTC is not present, DM.RFSTDTC is used.
The end dates for dosing are determined from ADSL.TRTEDTM. If ADSL.TRTEDTM is not present, ADSL.TRTEDT is used. If ADSL.TRTEDT is not present, DM.RFXENDTC is used. If DM.RFXENDTC is not present, the latest date in EX.EXENDTC is used. If EX.EXENDTC is not present, DM.RFENDTC is used.
For AE, CM, and CE, if the date listed is on or after the dosing start date, the event is considered treatment emergent.
Note: All events are considered pre-treatment for those subjects not on treatment.

1
The offset for the end of dosing is considered to be a defined number of days