The CM domain was used to represent prior psoriasis treatments and vaccinations received during the study, or in the 6 months prior to enrollment in the study. The WHO drug codes included are example decodes and sponsors should confirm accuracy if using them. The Device Identification domain (DI) is required to define the sponsor-defined identifier (SPDEVID) for the device used for the administration of the treatment, but is not shown in this example.
Shows the subject was previously treated with an "ANTIPSORIATIC" medication. CMPRESP and CMOCCUR are used to indicate that this was an occurrence of a pre-specified treatment.
|Rows 2-3:||Show the subject previously used biologic treatments. CMSCAT was used to categorize the medications used as "BIOLOGIC". Note that CMSTRF is blank, because the complete start date is available.|
|Row 4:||Shows the subject did not receive a vaccination in the 6 months prior to enrollment in the study.|
|Row 5:||Shows the subject had a flu vaccination during the study period. The sponsor used the CMSTDTC to determine that vaccination occurred during the study.|
|2||PS005||CM||3001||SYRINGE||2||EFALIZUMAB||efalizumab||ANTIPSORIATIC||BIOLOGIC||1||mg/kg||EVERY WEEK||SUBCUTANEOUS||OTHER-NOT RELATED TO EFFICACY/ ADVERSE EVENTS||2014-07-14||2012-03-15||2012-07-15|
EVERY 2 WEEKS
|5||PS005||CM||3001||5||INFLUENZA VACCINES||influenza vaccines||VACCINATION||2014-10-14||2014-10-14|