Clicking on the blue hyperlinked text of any ICSR # will bring users to a detailed Case Profile page for that specific FAERS case report. Case Profiles allow for enhanced case review including annotations, commenting, and individual case inclusion/exclusion or adjudication.
ICSRs can be accessed via the following pages/tools:
Drug/Adverse Event Analysis pages
Case Series Analysis tool
FAERS --> Cases Tab from any drug page
Below are example images and links to each page.
Drug/Adverse Event Analysis pages
From any Drug/AE Analysis page, scroll down to the “FAERS Cases” table, and click on an ISR.
Case Series Analysis Tool
From the Case Series Analysis (CSA) tool, enter in desired search criteria and click on “Case Review”. Within the Case Review table, click on an ISR number.
FAERS --> Cases Tab from any drug page
From any drug page within Evidex, click on the FAERS tab, then the “Cases” sub-tab. Click on an ICSR number to open the given Case Profile.
Case Profile Pages
From the Case Profile page, clicking the blue “Options” button in the upper right corner opens a drop-down menu for users to export the case as a pdf, send via email, or export and attach the case to an item within their Evidex Signal Management (ESM) module. (Click here for more information on ESM.) The “File Manager” found under the TOOLS drop-down menu from the top of any Evidex page lists all files that were emailed or attached to an ESM item within a given user’s organization.
The Case Profile lists all fields in the FAERS ICSR. Note that not all fields are required, and some may be blank. Users can hover over a row name to read more about the data contained in a given row.
Users can select options within the Case Settings box. “Data Mining” can be set to either “Exclude” or “Include” to specify whether this case should be included in data calculations for the Case Series Analysis tool (CSA). Read more about CSA here. “Case Series” can be set to show whether the reviewer wants to include or exclude the specific case within the Case Series they are evaluating for a potential safety signal. Changing this setting will not affect any data calculations within CSA.
Users can use the “Comments” section to add a new comment to a case or make changes in the Settings for a case. This enables users to keep track of cases they have already reviewed, document notes for a given case, and set priority for further review if related to a potential signal.
Click on “Add New Comment” to open the Comment box. Users can choose to share the comments with users within their organization (Public) or to Share with specific users. Any comment that includes a change in Status, Data Mining, or Case Series will be viewable by any other users within their organization.
Clicking on “Show Edit History” button at the top of the case will bring users to an Audit Log showing every change made to the Settings/Comments for the particular case. Users can enter criteria into the Search boxes and clicking on the blue “Search” button will return the requested results. Results in the “Details” table can further be filtered by the column header filters to segment the data. These results can be exported as a .csv or pdf by clicking the three-line menu in the upper right corner of the data table.
Users can also search across Signals, Inquiries, Actions, Requests, Reviews, and CMQ changes.
Clicking on a drug name within the Case Profile will navigate users to the given drug page within Evidex. Clicking on the adverse event term(s) at the bottom of the Case Profile will navigate users to the Drug/AE Analysis page for the given Primary Suspect drug.
Clicking on any edit icon for a field within a case profile will open an Annotations box for reviewers to add notes/annotations. Any Annotations will automatically be saved in Evidex, displaying red text that includes the user’s name, time stamp, date, and the notes included in the Annotation. This will be viewable by any other users within the user’s same organization.
