Case Scoring

Argus Signal Management supports Case Scoring.

A case score indicates how well populated a report is for a given product-event combination.

The case score is computed as the product of scores for the following categories:

• Event seriousness
• Product-event combination listedness
• Product-event combination causality
• Medical confirmation
• Case completeness

Oracle Empirica Signal computes the scores for the categories as follows:

Category	Variable	Computation
Event seriousness	Fatal Life-threatening Serious	If the event is fatal or life-threatening—5, or If the event is serious—3, or If none of the previous scenarios apply—1
Product-event combination listedness	Unlisted	If the event is listed on the drug/product label—3 If the event is not listed on the drug/product label—1
Product-event combination causality (for Sponsored Trial cases)	Case type Reporter related Reporter unrelated Company related Company unrelated Rechallenge positive Dechallenge positive	If the report is reporter related and company related—8, or If the report is reporter related or company related, and The rechallenge positive is yes or dechallenge positive is yes—8, or The rechallenge positive is no and dechallenge positive is no—4, or If the report is reporter unrelated and company unrelated—.25, or If the report is reporter unrelated or company unrelated—1, or If none of the previous scenarios apply—.5
Product-event combination causality (for Post Marketing Survey and Compassionate Use cases)	Case type Reporter related Reporter unrelated Company related Company unrelated Rechallenge positive Dechallenge positive	If the report is reporter related or company related, and The rechallenge positive is yes—8, or The dechallenge positive is yes—4, or The rechallenge positive is no and dechallenge positive is no—2, or If the report is reporter unrelated and company unrelated—.25, or If the report is reporter unrelated or company unrelated—1, or If none of the previous scenarios apply—.5
Product-event combination causality (for Spontaneous and Literature cases)	Case type Reporter related Reporter unrelated Company related Company unrelated Rechallenge positive Dechallenge positive	If the report is not company related or missing, and If rechallenge positive is yes—8, or If dechallenge positive is yes—4, or If neither rechallenge positive nor dechallenge positive are yes—2 If none of the previous scenarios apply—.25
Product-event combination causality (for cases of any type that is not listed in a previous row)	-	.5
Medical confirmation	-	If the report is medically confirmed—2, or If the report is not medically unconfirmed or missing—1
Case completeness	-	If the report has medical confirmation, drug start date, and event onset date defined, and If the report has patient gender, patient age, drug dose, drug indication, PT unevalauble, and event outcome defined—3, or If the previous scenario does not apply—2 If the report is missing medical confirmation, drug start date, or event onset date—1

• Thresholds
  Thresholds are used in the Significant Case Score views. All thresholds are connected via OR (any one signals).