SM_EVENT_PRODUCT Table

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

Configuration Variable Column Description

(Event Drug) As Determined Causality

DET_CAUSALITY_VE

As determined causality

(Event Drug) As Reported Causality

RPT_CAUSALITY_VE

As reported causality

(Event Drug) Case Number

CASE_NUM

Case number

(Event Drug) Dechallenge

DECHALLENGE_VE

Dechallenge

(Event Drug) Description Reported

DESC_REPTD

Description reported

(Event Drug) Event Sequence Number

EVENT_SEQ_NUM

Event sequence number

(Event Drug) Listedness Company Data Sheet

LISTEDNESS_CDS_VE

Event/product listedness from company datasheet

(Event Drug) Listedness Core Data Sheet

LISTEDNESS_CORE_VE

Event/product listedness from core data sheet

(Event Drug) Maximum Stop Dose Date

MAX_STOP_DATETIME_DV

Latest stop dose date

(Event Drug) Minimum Start Dose Date

MIN_START_DATETIME_DV

Earliest start dose date

(Event Drug) Onset Date

ONSET_DATE

Onset date of event

(Event Drug) Onset Delay

ONSET_DELAY

Onset delay from last dosage

(Event Drug) Onset Latency

OFFSET_LATENCY_TEXT_DV

Onset latency from first dosage

(Event Drug) Onset Latency Text

ONSET_LATENCY_TEXT_DV

Onset latency text

(Event Drug) Product Sequence Number

PROD_SEQ_NUM

Product sequence number

(Event Drug) PT

PT

Event Preferred Term

(Event Drug) Rechallenge YNU

RECHALLENGE_VE

Y/N/U: Rechallenge

(Event Drug) ValidEnd

VALIDEND

Valid end date

(Event Drug) ValidStart

VALIDSTART

Valid start date

(Event Drug/derived) Family Name

PROD_EXPOS_FAMILY_NAME_ DV

Product family name, with exposure name for known study products

(Event Drug/derived) Generic Name

PROD_EXPOS_GENERIC_ NAME_DV

Product generic name, with exposure name for known study products

(Event Drug/derived) Product Name

PROD_EXPOS_PRODUCT_ NAME_DV

Product name, with exposure name for known study products