SM_PRODUCT Table

Information about the Oracle Empirica Signal configuration variables from the SM_ PRODUCT table.

Configuration Variable Column Description

(Drug) Abuse YN

ABUSE_YN_VE

Y/N: Abuse

(Drug) Case Number

CASE_NUM

Case number

(Drug) Case Number

CASE_NUM

Case number

(Drug) Company Drug Code

CO_DRUG_CODE

Company drug code

(Drug) Dechallenge Date

DECHALL_DATE

Dechallenge date

(Drug) Dechallenge YNU

DECHALLENGE_VE

Y/N/U: Dechallenge flag

(Drug) Device YN

DEVICE_YN_VE

Y/N: Device

(Drug) Drug Sort ID

DRUG_SORT_ID

Drug sort order

(Drug) Drug YN

DRUG_YN_VE

Y/N: Product is a drug

(Drug) Duration

DRUG_DURATION_SECONDS

Duration text

(Drug) Formulation

FORMULATION_VE

Formulation

(Drug) Indication List

INDICATION_LIST_DV

List of indications for product

(Drug) Interaction YNU

INTERACTION_YNU_VE

Y/N/U: Drug interaction

(Drug) Onset Latency

LATENCY_TEXT_DV

Text describing onset latency from first dosage

(Drug) Overdose YN

OVERDOSE_YN_VE

Y/N: Overdose

(Drug) Product Exposure Product Name

EXPOS_PRODUCT_NAME_VE

Product name for exposure product

(Drug) Product Family Name

PROD_FAMILY_NAME_VE

Product family name

(Drug) Product Generic Name

PROD_GENERIC_NAME_VE

Product generic name

(Drug) Product Name

PROD_PRODUCT_NAME_VE

Product name

(Drug) Product Sequence Number

PROD_SEQ_NUM

Product sequence number

(Drug) Product Type

DRUG_TYPE_VE

Product type (suspect, concomitant, treatment)

(Drug) Rechallenge YNU

RECHALLENGE_VE

Y/N/U: Rechallenge performed

(Drug) Route (Patient)

ROUTE_VE

Route of administration (patient)

(Drug) Total Dosage

TOTAL_DOSE

Auto-calculated by Argus, based on daily dose, duration, frequency

(Drug) Total Dosage Units

TOTAL_DOSE_UNIT_VE

Value for the total dosage units

(Drug) Vaccine YN

VACCINE_YN_VE

Y/N: Product is a vaccine

(Drug) ValidEnd

VALIDEND

Valid end date

(Drug) ValidEnd

VALIDEND

Valid end date

(Drug) ValidStart

VALIDSTART

Valid start date

(Drug) ValidStart

VALIDSTART

Valid start date

(Drug) WHO Drug Code

WHO_DRUG_CODE

WHO drug code

(Drug/derived) Drug Duration Text

DRUG_DURATION_TEXT_DV

Drug duration converted to text

(Drug/derived) Family Name

FAMILY_NAME_VE

Product family name

(Drug/derived) Preferred Product Name

PREFERRED_PRODUCT_ NAME_DV

Drug name variable designed for data mining. Product family name, when available, else the product generic name, else product name. Exposure names are used for known study products.

(Drug/derived) Preferred PSUR Product Name

PREF_PSUR_PRODUCT_NAME

PSUR Group Name (if defined), otherwise Preferred Product Name

(Drug/derived) Product Expo- sure Family Name

PROD_EXPOS_FAMILY_NAME_ DV

Product family name, with expo- sure name for known study products

(Drug/derived) Product Exposure Generic Name

PROD_EXPOS_GENERIC_ NAME_DV

Product generic name, with exposure name for known study products

(Drug/derived) Product Exposure Name

PROD_EXPOS_PRODUCT_ NAME_DV

Product name, with exposure name for known study products