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

Last updated on JULY 18, 2019

Applies to:

Oracle Health 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
 

 

Oracle® Health Sciences Argus Mart Data

Release Notes

Release 8.0

E56900-01

September 2014

This document includes the following sections:

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 VariableTableColumn
(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:

TableType 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 NameSuspect?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 NamePTsNarrow 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 ConfigurationDescription
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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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 VariableColumnDescription
(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

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Access to Oracle Support

Oracle customers have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.


Release Notes, Release 8.0

E56900-01

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In this Document
Purpose
 Oracle® Health Sciences Argus Mart Data
 Introduction
 New in the Argus Mart 7.0.3 Release
 MedDRA Standardized MedDRA Query (SMQ) Support
 Argus Mart Data Tables and Views
 Tables
 Additional Views
 Data Configurations
 Data Mining Table Schema
 SM_CASE Table
 SM_CAUSE_OF_DEATH Table
 SM_DOSE Table
 SM_EVENT_PRODUCT Table
 SM_EVENT View
 SM_EVENT_PLUS_SMQ Table
 SM_EVENT_PLUS_SMQ_NARROW View
 SM_INDICATIONS Table
 SM_INGREDIENTS Table
 SM_LAB Table
 SM_NARRATIVE Table
 SM_NEONATES Table
 SM_PARENT_INFO Table
 SM_PAT_HIST Table
 SM_PREGNANCY Table
 SM_PRODUCT Table
 SM_REPORTERS Table
 Corrected Issues
 Known Issues
 Documentation Accessibility
Details

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