Products Page

You access all the functions you can perform on an individual product from the Products page.

  1. In Oracle Empirica Signal, from the navigation pane on the left, click the Signal Review icon (SigReviewIcon).

    The Products page appears and contains:

    • Products By drop-down and cards: Using the Products By drop-down list, you can group the products you are tracking by product group, category, complexity, organization, or assigned reviewer. The grouping is reflected in the cards displayed below the Products By drop-down. For each grouping, there is a card that includes all products as well as the individual elements of the grouping. You can move back and forth through the cards with the dots below them or the right-arrow at the right. Selecting a card updates the graphic details panel and filters the Products table.
    • Products table: Below the cards is a table containing the individual products that match the Products By filter. If you select the All card, all monitored products appear. If you select a product group card, only the products in that group appear. The graphic details on the right update to match the selection.
    • Graphic details panel: To the right of the Products By panel and the Products table is a summary panel of either the selected Products By card or the selected Product. The panel contains sections that can be expanded or collapsed. The sections available depend on the selected item and the signal configuration. The Tracked Alerts and Informational Alerts sections are always available. The Open Topics section is available if your signal configuration is integrated with Topics. The Notes section is available when you select a Product. You can show or hide the sections in the graphic details panel.

The following table lists the AERS Signal Management-specific alert columns that you can display in the Products table in default order.

Column Name Column Description

Drug

Drug term

SDR

Number of unlisted events with new reports and EB05 >= 2

FATAL

Number of events with new fatal reports since the prior period

DME

Number of designated medical events with new reports since the prior period

TME

Number of intensively monitored events (targeted medical events) with new reports since the prior period

PEDIATRIC

Number of events newly exceeding threshold [EB05(peds)>=2 and EB05(peds)>EB95(adult)] since the prior period (where peds = ages 0 through 17, and adult = ages 18 through 64)

ELDERLY

Number of events newly exceeding threshold [EB05(elderly)>=2 and EB05(elderly)>EB95(adult)] since the prior period (where adult = ages 18 through 64, and elderly = ages 65 and above)

NEW

Number of events with new reports since the prior period

SERIOUS

Number of events with new serious reports since the prior period

FEMALE

Number of events newly exceeding threshold [EB05(female)>=2 and EB05(female)>EB95(male)] since the prior period

MALE

Number of events newly exceeding threshold [EB05(male)>=2 and EB05(male)>EB95(female)] since the prior period

INTERACT

Number of events newly exceeding threshold [INTSS>2] since the prior period