Oracle® Health Sciences Argus Mart Data 8.0 Release Notes (Doc ID 1930215.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Empirica Signal
Information in this document applies to any platform.

Purpose

Oracle® Health Sciences Argus Mart Data 8.0 Release Notes.

Oracle® Health Sciences Argus Mart Data

Release Notes

Release 8.0

E56900-01

September 2014

This document includes the following sections:

Introduction
New in the Argus Mart 7.0.3 Release
MedDRA Standardized MedDRA Query (SMQ) Support
Argus Mart Data Tables and Views
Data Configurations
Data Mining Table Schema
Corrected Issues
Known Issues
Documentation Accessibility

Introduction

These release notes describe the Argus Mart data for use with Empirica™ Signal release 8.0 and higher.

New in the Argus Mart 7.0.3 Release

The data configurations shipped with this release have been changed as follows. If you already have Empirica Signal data configurations for Argus Mart, you may want to make these changes as well.

The variables in the following table were added:

Configuration Variable	Table	Column
(Case/derived) Event List	SM_CASE	EVENT_LIST_DV
(Dose) Case Number	SM_DOSE	CASE_NUM
(Dose/derived) Product Exposure Family Name	SM_DOSE	PROD_EXPOS_FAMILY_NAME_DV
(Dose/derived) Product Exposure Generic Name	SM_DOSE	PROD_EXPOS_GENERIC_NAME_DV
(Dose/derived) Product Exposure Name	SM_DOSE	PROD_EXPOS_PRODUCT_NAME_DV
(Dose) Total Regimen Dosage	SM_DOSE	TOTAL_REG_DOSE
(Dose) ValidEnd	SM_DOSE	VALIDEND
(Dose) ValidStart	SM_DOSE	VALIDSTART
(Drug/derived) Preferred PSUR Product Name	SM_PRODUCT	PREF_PSUR_PRODUCT_NAME

The drilldown map was enhanced:
- EVENT_LIST_DV added to drilldown type LIST
- EVENT_DIAGNOSIS_VE added to drilldown type EVENT
Case Number variables are now available for querying.

MedDRA Standardized MedDRA Query (SMQ) Support

The Argus Mart data includes the assignment of SMQs based on criteria defined in the Introductory Guide for Standardised MedDRA Queries (SMQs) Version x.y, published by the International Federation of Pharmaceutical Manufacturers and Associations.

The SMQ support is as follows:

Narrow and broad definitions of SMQs are implemented.
Select Algorithmic SMQs are implemented.
The event variable (Event/SMQ) PT_plus_SMQ includes values for all PTs and SMQs associated with each report, where the SMQ records have been inserted into the data as part of data preparation. Event variable (Event/Narrow SMQ) PT_plus_Narrow_SMQ provides only PTs and Narrow SMQ data for data mining, querying, and reporting.

Note:

There are no hierarchy values for SMQs in data mining results. Also, the prepared source data does not have hierarchy values for SMQs; thus hierarchy values for SMQs do not appear in second-level drilldown (the Case Details page). Also note that SMQs do not appear in the MedDRA Hierarchy Browser.

Calculations made by MGPS data mining runs are not affected by the addition of SMQ values in the Argus Mart data.

The following documents are available from the Empirica Signal and Topics Online Help when you access the help topic Release Notes and Other Documents (under Getting Started in the Table of Contents for the Help):

Introductory Guide for Standardised MedDRA Queries (SMQs) Version x.y
Introductory Guide MedDRA Version x.y

Argus Mart Data Tables and Views

Tables

The primary tables in the Argus Mart Data account are:

Table	Type of Data
SM_CASE	Demographic
SM_CAUSE_OF_DEATH	Cause of death
SM_DOSE	Dosing
SM_EVENT_PLUS_SMQ	PT plus all SMQs
SM_EVENT_PRODUCT	Event-Product
SM_INDICATIONS	Indications
SM_INGREDIENTS	Ingredients
SM_LAB	Lab
SM_NARRATIVE	Narratives
SM_NEONATES	Neonate
SM_PARENT_INFO	Parent information
SM_PAT_HIST	Patient History
SM_PRODUCT	Product
SM_REPORTERS	Reporter

Additional Views

SM_PRODUCT table has a view that excludes records for concomitant drugs:

Table or View Name	Suspect?	Concomitant?
SM_PRODUCT table	P	P
SM_PRODUCT_S view	P

SM_EVENT_PLUS_SMQ table views exclude or include different SMQs:

Table or View Name	PTs	Narrow SMQs?	Broad SMQs?	Alg. SMQs?
SM_EVENT_PLUS_SMQ table	P	P	P	P
SM_EVENT_PLUS_SMQ_NARROW view	P	P
SM_EVENT view	P

Data Configurations

The Argus Mart data release includes the following configurations:

Standard Configuration	Description
ARGUS (S)	All ARGUS datamart cases. Suspect products only.
ARGUS (S + C)	All ARGUS datamart cases. Suspect and concomitant products only.

Tip:

The (S) or (S + C) abbreviation in the configuration name indicates whether that configuration includes only records for drugs that are identified as Suspect (S) in the report, or records for both the Suspect drugs and Concomitant drugs (S + C).

For a complete list of the variables that are included in configurations, see Data Mining Table Schema.

For a complete list of the variables available for inclusion in configurations, see the Oracle Argus Mart ETL Mapping Document.

Data Mining Table Schema

The following tables and views have been prepared for use with data mining. The standard Empirica Signal data configurations (described above) are based on these tables.

SM_CASE Table

Information about the Empirica Signal configuration variables from the SM_CASE table follows.

Configuration Variable	Column	Description
(Case) Blinding Status	UNBLINDING_STATUS_VE	Study blinding status
(Case) Case Number	CASE_NUM	Case number
(Case) Conmed List	CONMED_LIST_DV	Concomitant medication list
(Case) Country of Incidence	COUNTRY_VE	Country in which the case occurred
(Case) Device Case YN	DEVICE_CASE_YN	Y/N: Case has at least one suspect device
(Case) Drug Case YN	DRUG_CASE_YN	Y/N: Case has at least one suspect drug
(Case) Followup Date	FOLLOWUP_DATE	Date of follow-up
(Case) Followup Number	REV	Case follow-up number
(Case) Initial Report Date	INIT_REPT_DATE	Date first reported
(Case) Listedness	LISTEDNESS_VE	Case listedness
(Case) Outcome	EVT_OUTCOME_VE	Case outcome
(Case) Patient Ethnicity	ETHNICITY_VE	Patient Ethnicity
(Case) Patient Height cm	PAT_HEIGHT_CM	Patient height in centimeters
(Case) Patient Weight Kg	PAT_WEIGHT_KG	Patient weight in kilograms
(Case) Pregnancy	PREGNANCY_VE	Pregnancy case (Yes/No/UNK/NA)
(Case) Protocol Number	PROTOCOL_NUM	Case protocol number
(Case) Report Type	REPORT_TYPE_VE	Type of report (spontaneous, clinical trial, etc.)
(Case) Seriousness Text	SERIOUSNESS_TEXT_DV	Seriousness text
(Case) Study Description	STUDY_DESC	Case study description
(Case) Study Name	BLIND_NAME	Study name
(Case) Study Number	STUDY_NUM	Case study number
(Case) Study Phase	DEV_PHASE_VE	Case study phase
(Case) Study Type	STUDY_TYPE_VE	Case study type
(Case) SUSAR Case YN	SUSAR_YN_VE	Y/N: SUSAR case
(Case) Vaccine Case YN	VACCINE_CASE_YN	Y/N: Case has at least one suspect vaccine
(Case) ValidEnd	VALIDEND	Valid end date
(Case) ValidStart	VALIDSTART	Valid start date
(Case/derived) AgeGroup3	AGE_GROUP_3_DV	Age group in years: 00_64, 65_above, UNK
(Case/derived) AgeGroup4	AGE_GROUP_4_DV	Age group in years: 00_17, 18_64, 65_above, UNK
(Case/derived) AgeGroup9	AGE_GROUP_9_DV	Age group in years: 00_01, 02_04, 05_12, 13_17, 18_45, 46_64, 65_74, 75_above, UNK
(Case/derived) Event List	EVENT_LIST_DV	List of preferred terms. (S) indicates serious; (U) indicates unlisted for primary suspect drug. Listedness is determined by CDS listedness for trial reports, otherwise CORE listedness.
(Case/derived) Fatal YN	FATAL_YN_DV	Y/N: Case is fatal
(Case/derived) HCP YNU	HCP_YNU_DV	Y/N/U: Indicates if case has at least one reporter who is a Health Professional
(Case/derived) Last Significant Update	LAST_SIGNIF_UPDATE_DV	Date associated with the last significant followup for the case
(Case/derived) Last Significant Update Month	LAST_SIGNIF_UPDATE_MONTH_DV	Subset month associated with the last significant followup for the case
(Case/derived) Last Significant Update Quarter	LAST_SIGNIF_UPDATE_QUARTER_DV	Subset quarter associated with the last significant followup for the case. These quarters follow Schedule A.
(Case/derived) Last Significant Update Week	LAST_SIGNIF_UPDATE_WEEK_DV	Subset ISO week associated with the last significant followup for the case
(Case/derived) Patient Age Years	AGE_YEARS_DV	Age converted to years
(Case/derived) Patient BMI	BMI_DV	Patient body mass index
(Case/derived) Patient Gender	GENDER_CLEAN_VE	Patient's sex (F/M/U) , with NULL converted to U
(Case/derived) Received Half Year	RECEIVED_HALFYEAR_DV	Half-year of initial date of report (e.g., 200306, 200312, etc.)
(Case/derived) Received Month	RECEIVED_MONTH_DV	Month of initial date of report (e.g., 200304)
(Case/derived) Received Quarter	RECEIVED_QUARTER_DV	Quarter-year of initial date of report (e.g., 200303, 200306, etc.)
(Case/derived) Received Year	RECEIVED_YEAR_DV	Year of initial date of report
(Case/derived) Seriousness YN	SERIOUSNESS_VE	Y/N: Case is serious
(Case/derived) STANDARD_STRATA	STANDARD_STRATA_AG9_DV	Gender + agegroup9 + received year
(Case/derived) STANDARD_STRATA_AG4	STANDARD_STRATA_AG4_DV	Gender + agegroup4 + received year
(Case/derived) STANDARD_STRATA_ARGUS	STANDARD_STRATA_DV	Gender + ARGUS agegroup + received
(Case/derived) Subset_3Year_Group	SUBSET_3YEAR_GROUP_DV	Data up to 2000 lumped together in a single group. Post 2000 categorizes reports into three year groups (as in [2001-2003]) based on the initial date
(Case/derived) Subset_Month	SUBSET_MONTH_DV	Month of initial date of report. Dates prior to 2000 grouped together into larger sets
(Case/derived) Subset_Quarter	SUBSET_QUARTER_DV	Quarter of initial date of report, following Schedule A. Dates prior to 2000 are grouped together into larger sets
(Case/derived) Subset_Week	SUBSET_WEEK_DV	ISO week of initial date of report. Dates prior to 2000 are grouped together into larger sets
(Case/derived) Subset_Year	SUBSET_YEAR_DV	Year of initial date of report. Dates prior to 2000 are grouped together into larger sets
(Case/derived) Suspect Drug List	SUSPDRUG_LIST_DV	List of suspect products. (P) indicates primary suspect product. * indicates company product.
(Case/derived) Treatment List	TREATMENT_LIST_DV	List of treatment products

SM_CAUSE_OF_DEATH Table

Information about the Empirica Signal configuration variables from the SM_CAUSE_OF_DEATH table follows.

Configuration Variable	Column	Description
(Cause of Death) Autopsy Results	RESULTS_VE	Status of autopsy results
(Cause of Death) Case Number	CASE_NUM	Case number
(Cause of Death) Cause of Death Autopsy	CAUSE_AUTOPSY	Autopsy cause of death
(Cause of Death) Cause of Death Reported	CAUSE_REPTD	Death cause as reported
(Cause of Death) Cause Type	CAUSE_TYPE_VE	Cause of death / autopsy result
(Cause of Death) Date of Death	DEATH_DATE	Date of death
(Cause of Death) Detailed Cause of Death	DETAILED_CAUSE	Detailed cause of death
(Cause of Death) HLGT	CAUSE_HLGT	Death cause HLGT
(Cause of Death) HLT	CAUSE_HLT	Death cause HLT
(Cause of Death) SOC	CAUSE_SOC	Death cause SOC
(Cause of Death) Sort ID	CAUSE_SORT_ID	Cause of death sort order
(Cause of Death) Term Type	TERM_TYPE_VE	Term type
(Cause of Death) ValidEnd	VALIDEND	Valid end date
(Cause of Death) ValidStart	VALIDSTART	Valid start date

SM_DOSE Table

Information about the Empirica Signal configuration variables from the SM_DOSE table follows.

Configuration Variable	Column	Description
(Dose) Case Number	CASE_NUM	Case number
(Dose/derived) Product Exposure Family Name	PROD_EXPOS_FAMILY_NAME_DV	Product family name, with exposure name for known study products
(Dose/derived) Product Exposure Generic Name	PROD_EXPOS_GENERIC_NAME_DV	Product generic name, with exposure name for known study products
(Dose/derived) Product Exposure Name	PROD_EXPOS_PRODUCT_NAME_DV	Product name, with exposure name for known study products
(Dose) Total Regimen Dosage	TOTAL_REG_DOSE	Total dosage regimen as reported
(Dose) ValidEnd	VALIDEND	Valid end date
(Dose) ValidStart	VALIDSTART	Valid start date

SM_EVENT_PRODUCT Table

Information about the Empirica Signal configuration variables from the SM_EVENT_PRODUCT table follows.

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

SM_EVENT View

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

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

Information about the 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

SM_EVENT_PLUS_SMQ Table

Information about the Empirica Signal configuration variables from the SM_EVENT_PLUS_SMQ table follows.

Configuration Variable	Column	Description
(Event/SMQ) Case Number	CASE_NUM	Case number
(Event/SMQ) PT_plus_SMQ	EVENT_PT	PT or SMQ Name; includes narrow, broad, and 5 algorithmic SMQs
(Event/SMQ) Term Type	EVENT_TYPE	Type of term: PT/SMQ
(Event/SMQ) ValidEnd	VALIDEND	Valid end date
(Event/SMQ) ValidStart	VALIDSTART	Valid start date

SM_EVENT_PLUS_SMQ_NARROW View

The SM_EVENT_PLUS_SMQ_NARROW view on the SM_EVENT_PLUS_SMQ table is created using the following SQL WHERE clause:

WHERE INCLUDE_YN = 'Y' AND (EVENT_TYPE = 'PT' OR (EVENT_TYPE = 'SMQ' AND IS_NARROW = 'Y')

As a result, the PT_plus_Narrow_SMQ variable offered by this view includes MedDRA preferred terms and narrow standardized MedDRA queries for data mining. Information about the Empirica Signal configuration variables from the SM_EVENT_PLUS_SMQ_NARROW view follows.

Configuration Variable	Column	Description
(Event/Narrow SMQ) Case Number	CASE_NUM	Case number
(Event/Narrow SMQ) PT_plus_Narrow_SMQ	EVENT_PT	PT or Narrow SMQ Name
(Event/Narrow SMQ) Term Type	EVENT_TYPE	Type of term: PT/SMQ
(Event/Narrow SMQ) ValidEnd	VALIDEND	Valid end date
(Event/Narrow SMQ) ValidStart	VALIDSTART	Valid start date

SM_INDICATIONS Table

Information about the Empirica Signal configuration variables from the SM_INDICATIONS table follows.

Configuration Variable	Column	Description
(Indication) Case Number	CASE_NUM	Case number
(Indication) HLGT	IND_HLGT	Indication High Level Group Term
(Indication) HLT	IND_HLT	Indication High Level Term
(Indication) LLT	IND_LLT	Indication Low Level Term
(Indication) PT	IND_PREF_TERM_DV	Indication Preferred Term
(Indication) SOC	IND_SOC	Indication System Organ Class
(Indication) ValidEnd	VALIDEND	Valid end date
(Indication) ValidStart	VALIDSTART	Valid start date
(Indication/derived) Family Name	PROD_EXPOS_FAMILY_NAME_DV	Product family name, with exposure name for known study products
(Indication/derived) Generic Name	PROD_EXPOS_GENERIC_NAME_DV	Product generic name, with exposure name for known study products
(Indication/derived) Product Name	PROD_EXPOS_PRODUCT_NAME_DV	Product name, with exposure name for known study products

SM_INGREDIENTS Table

Information about the Empirica Signal configuration variables from the SM_INGREDIENTS table follows.

Configuration Variable	Column	Description
(Ingredient) Case Number	CASE_NUM	Case number
(Ingredient) Concentration	CONCENTRATION	Concentration
(Ingredient) Concentration Unit	CONCENTRATION_UNITS_VE	Concentration unit
(Ingredient) Ingredient	INGREDIENT_VE	Ingredient
(Ingredient) Ingredient Sequence Number	ITEM	Ingredient sequence number
(Ingredient) Product Sequence Number	SEQ_NUM	Product sequence number
(Ingredient) ValidEnd	VALIDEND	Valid end date
(Ingredient) ValidStart	VALIDSTART	Valid start date

SM_LAB Table

Information about the Empirica Signal configuration variables from the SM_LAB table follows.

Configuration Variable	Column	Description
(Lab) Case Number	CASE_NUM	Case Number
(Lab) Lab Results	LAB_RESULTS	Lab Results
(Lab) Test Name	LAB_TEST_NAME	Test Name
(Lab) Valid End	VALIDEND	Valid end date
(Lab) Valid Start	VALIDSTART	Valid start date

SM_NARRATIVE Table

Information about the Empirica Signal configuration variables from the SM_NARRATIVE table follows.

Configuration Variable	Column	Description
(Narrative) Case Number	CASE_NUM	Case number
(Narrative) Narrative	NARRATIVE_DV	Narrative
(Narrative) Type	NARRATIVE_TYPE_DV	Narrative type
(Narrative) ValidEnd	VALIDEND	Valid end date
(Narrative) ValidStart	VALIDSTART	Valid start date

SM_NEONATES Table

Information about the Empirica Signal configuration variables from the SM_NEONATES table follows.

Configuration Variable	Column	Description
(Neonates) APGAR Score #1	APGAR1	APGAR score #1
(Neonates) APGAR Score #2	APGAR2	APGAR score #2
(Neonates) APGAR Score #3	APGAR3	APGAR score #3
(Neonates) Birth Type	BIRTH_TYPE_VE	Birth type
(Neonates) Case Number	CASE_NUM	Case number
(Neonates) Delivery Notes	NOTES	Delivery notes
(Neonates) Delivery Type	DELIVERY_TYPE_VE	Delivery type
(Neonates) Fetal Outcome	FETAL_OUTCOME_VE	Fetal outcome
(Neonates) Sort ID	SORT_ID	Neonates sort order
(Neonates) ValidEnd	VALIDEND	Valid end date
(Neonates) ValidStart	VALIDSTART	Valid start date
(Neonates) Weight in Grams	WEIGHT_GRAMS	Weight in grams

SM_PARENT_INFO Table

Information about the Empirica Signal configuration variables from the SM_PARENT_INFO table follows.

Configuration Variable	Column	Description
(Parent Info) Case Number	CASE_NUM	Case number
(Parent Info) Parent Age	AGE	Parent age
(Parent Info) Parent Age Unit	AGE_UNIT_VE	Parent age unit
(Parent Info) Parent Breastfeeding YN	BREASTFEEDING_VE	Y/N: Parent breastfeeding
(Parent Info) Parent Date of Birth	DOB	Parent date of birth
(Parent Info) Parent Date of LMP	DATE_OF_LMP	Parent date of LMP
(Parent Info) Parent Gender	GENDER_VE	Parent's sex
(Parent Info) Parent Medical History Text	MED_HIST_TEXT	Parent's medical history text
(Parent Info) ValidEnd	VALIDEND	Valid end date
(Parent Info) ValidStart	VALIDSTART	Valid start date

SM_PAT_HIST Table

Information about the Empirica Signal configuration variables from the SM_PAT_HIST table follows.

Configuration Variable	Column	Description
(Patient History) Case Number	CASE_NUM	Case number
(Patient History) Condition	CONDITION	Patient history condition
(Patient History) Condition Continuing YN	CONDITION_CONTINUING_VE	Y/N: Is patient history condition ongoing
(Patient History) Condition Indication	CONDITION_INDICATION	Patient history indication
(Patient History) Condition Note	CONDITION_NOTE	Patient history note
(Patient History) Condition Parent YN	CONDITION_PARENT_YN_VE	Y/N: Patient history condition is for parent
(Patient History) Condition Reaction	CONDITION_REACTION	Patient history condition reaction
(Patient History) Condition Sort ID	CONDITION_SORT_ID	Patient history condition sort order
(Patient History) Condition Type	CONDITION_TYPE_VE	Condition type
(Patient History) ValidEnd	VALIDEND	Valid end date
(Patient History) ValidStart	VALIDSTART	Valid start date

SM_PREGNANCY Table

Information about the Empirica Signal configuration variables from the SM_PREGNANCY table follows.

Configuration Variable	Column	Description
(Pregnancy) Breastfeeding YN	BREASTFEEDING_YN_VE	Y/N: Breastfeeding
(Pregnancy) Case Number	CASE_NUM	Case number
(Pregnancy) Date of LMP	DATE_OF_LMP	Date of LMP
(Pregnancy) Gestation Exposure Period	GESTATION_EXPOSURE_PERIOD	Weeks from LMP to drug exposure
(Pregnancy) Number of Fetus	NUMBER_OF_FETUS	Number of fetus
(Pregnancy) Parent	PARENT_VE	Parent flag
(Pregnancy) Prospective	PROSPECTIVE_VE	Prospective
(Pregnancy) Trimester of Exposure	EXP_TRIMESTER_VE	Trimester of exposure
(Pregnancy) ValidEnd	VALIDEND	Valid end date
(Pregnancy) ValidStart	VALIDSTART	Valid start date
(Pregnancy) Weeks at Onset	WEEKS	Weeks at onset
(Pregnancy) Breastfeeding YN	BREASTFEEDING_YN_VE	Y/N: Breastfeeding

SM_PRODUCT Table

Information about the Empirica Signal configuration variables from the SM_PRODUCT table follows.

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 Exposure Family Name	PROD_EXPOS_FAMILY_NAME_DV	Product family name, with exposure 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

SM_REPORTERS Table

Information about the Empirica Signal configuration variables from the SM_REPORTERS table follows.

Configuration Variable	Column	Description
(Report Source) Case Number	CASE_NUM	Case number
(Report Source) HCP Flag YNU	HCP_YNU_VE	Y/N/U: Reporter is health care professional
(Report Source) Report Type	REPORTER_TYPE_VE	Report type
(Report Source) Sort ID	REPORT_SOURCE_SORT_ID	Report source sort order
(Report Source) ValidEnd	VALIDEND	Valid end date
(Report Source) ValidStart	VALIDSTART	Valid start date

Corrected Issues

16381690 - Failed index creation error messages occur

Previously, when validating Argus configurations, error messages regarding failed index creation appeared, but could be ignored. These messages no longer appear.

16381701 - Select Available Values list is not updated for added configuration variables

Previously, if you added variables to the Argus Mart data configurations, and if the Selection Type was designated as Distinct Value List, any new values that appeared for that variable in subsequent data refreshes would not appear in the Select Available Values popup. Users had to type the values directly into the field, rather than use Select Available Values.

In this release, values in the Select Available Values popup include all new values that appear in subsequent data refreshes. Users no longer need to type values into the field. [formerly 20696]

17340224 - After editing Event Hierarchy Version Table in Empirica Signal, data refresh will fail

Previously, after editing the Event Hierarchy Version Table in Empirica Signal subsequent data refreshes failed.

This issue has been fixed. The Event Hierarchy Version Table can be edited within Empirica Signal without causing a failure in subsequent data refreshes.

Known Issues

This section describes issues that are known to exist in the Argus Mart data.

16391714 - Empirica Signal does not support Argus Mart multi-tenant deployment

Multi-tenant deployments are not supported with Empirica Signal.

Documentation Accessibility

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Release Notes, Release 8.0

E56900-01

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