SM_CASE Table
Information about the Oracle Empirica Signal configuration variables from the SM_CASE table.
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, other- wise 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 follow-up for the case |
(Case/derived) Last Significant Update Month |
LAST_SIGNIF_UPDATE_ MONTH_DV |
Subset month associated with the last significant follow-up for the case |
(Case/derived) Last Significant Update Quarter |
LAST_SIGNIF_UPDATE_ QUARTER_DV |
Subset quarter associated with the last significant follow-up 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 follow-up 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 |
I
SO 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 |
Parent topic: Data Mining Table Schema