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
|
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
|
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
|
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
|
- Thresholds
Thresholds are used in the Significant Case Score views. All thresholds are connected via OR (any one signals).
Parent topic: Argus Signal Management