SM_EVENT View

The SM_EVENT view on the SM_EVENT_PLUS_SMQ table is created using a SQL WHERE clause.

The SM_EVENT view on the SM_EVENT_PLUS_SMQ table is created using this SQL WHERE clause:

WHERE EVENT_TYPE = 'PT' AND INCLUDE_YN = 'Y'

Information about the Oracle Empirica Signal configuration variables from the SM_EVENT view on the SM_EVENT_PLUS_SMQ table follows.

Configuration Variable Column Description

(Event) Associated with Rechallenge YN

RECHALL_RELATED_YN_VE

Y/N: Associated with rechallenge

(Event) Case Number

CASE_NUM

Case number

(Event) Congenital Anomaly YN

SERIOUS_CONGEN_ANOM_VE

Y/N: Event congenital anomaly seriousness criteria

(Event) Death YN

SERIOUS_DEATH_VE

Y/N: Event death seriousness criteria

(Event) Detail

DETAILS_LT

Event detail

(Event) Disability YN

SERIOUS_DISABLE_VE

Y/N: Event disability seriousness criteria

(Event) Event Diagnosis YN

EVENT_DIAGNOSIS_VE

Y/N: Event diagnosis

(Event) Event Outcome

EVENT_OUTCOME_VE

Event outcome

(Event) Frequency

EVT_FREQ_VE

Event frequency

(Event) HLGT

EVENT_HLGT

Event High Level Group Term

(Event) HLT

EVENT_HLT

Event High Level Term

(Event) Hospitalized YN

SERIOUS_HOSP_VE

Y/N: Event hospitalized seriousness criteria

(Event) Intensity

EVENT_INTENSITY_VE

Event intensity

(Event) Lack of Efficacy YN

EFFICACY_YN_VE

Y/N: Lack of efficacy

(Event) Life-threatening YN

SERIOUS_LIFE_THREAT_VE

Y/N: Event life-threatening seriousness criteria

(Event) LLT

EVENT_LLT

Event Lower Level Term

(Event) Medically Serious YN

MED_SERIOUS_VE

Y/N: Medically serious event

(Event) Onset Date

ONSET_DATE

Onset date of event

(Event) Other Details

SC_OTHER_TEXT

Details of other seriousness criteria

(Event) Other YN

SERIOUS_OTHER_VE

Y/N: Event other seriousness criteria

(Event) Patient Prior History YNU

PAST_HIST_VE

Y/N/U: Patient has prior history?

(Event) PT

EVENT_PT

Event Preferred term

(Event) Req Intervention YN

SERIOUS_INTERVENTION_VE

Y/N: Event intervention seriousness criteria

(Event) Sequence Number

EVENT_SEQ_NUM

Event sequence number

(Event) Serious YN

EVENT_SERIOUSNESS_VE

Y/N: Event seriousness

(Event) SOC

SOC

Event System Organ Class

(Event) SOC Abbrev

EVENT_SOC

Event System Organ Class abbreviation

(Event) Sort ID

EVENT_SORT_ID

Event sort order

(Event) Treatment Received YNU

TREATED_YNU_VE

Y/N/U: Treatment received

(Event) ValidEnd

VALIDEND

Valid end date

(Event) ValidStart

VALIDSTART

Valid start date

(Event/derived) Duration Text

EVENT_DURATION_TEXT_DV

Text describing duration of event. Calculated by Argus from onset date to event stop date

(Event/derived) Onset Delay

ONSET_DELAY_TEXT_DV

Text describing onset delay from last dosage

(Event/derived) Onset Latency

ONSET_LATENCY_TEXT_DV

Text describing onset latency from first dosage

(Event/derived) Seriousness Criteria

EVENT_SERIOUSNESS_TEXT_ DV

Summary of event seriousness criteria. Combination of the letters FLMDCIHO, for fatal, life threat, med significant, disability, congen anom, intervention, hosp, other