Description
To calculate background rates for any specific adverse event (preferred term) for a particular underlying condition, the user can click the “Background Rate Analysis” button from the home page to access the module. This module is also accessible from the Custom Analytics menu on the top right section of the Evidex web site.
From the Background Rate Analysis page, user can select the following criteria to calculate a background rate:
1) Source of Data (such as TriNetX DataWorks (US))
2) Indication/Condition (such as Ovarian Cancer)
3) Adverse Event at the MedDRA Preferred Term level (such as Anaemia)
4) Observed Rate (This section is reserved as of Evidex Release 1.48 and will be available in a future release)
After selecting all criteria, the user can click the Background Rate Summary to tab to see the results. The following statistics are displayed for background rates analysis
1. Overall Cases – number of patients experiencing the selected adverse event within 5 years of diagnosis of the underlying condition.
2. Background Incidence Rate – Incidence rate of patients experiencing the selected adverse event during the 5 years after earliest diagnosis with the selected condition.
3. Background Cases per 100 Patient Years: Patient Time analysis - takes into consideration the time the patient had the underlying condition before they experienced the adverse event selected.
As of Release 1.48, background rates are calculated using the TriNetX DataWorks (US) network which covers 50+ Health Care Organizations and 90M+ Patient Lives. MedDRA Preferred Terms were mapped to ICD-10 Diagnosis codes by the TriNetX data analytics team. Observed Rates will be available in a future release.