serviceData analysis Outsourcing Service

Signal Score Report

Signals are calculated according to various settings and provided as a score report in CSV file format. All reported adverse events in regard to the selected drugs are extracted, and the number of cases reported, the number of adverse events, various score values, etc. are summarized in a table.

More criteria, include drug(s) selection, suspected drug setting, specifications setting such as period setting, and other detailed conditions such as “collectively count all target adverse events” and “generate calculation results using SMQ” can be set. The service can be rendered in a single delivery or on a regular basis at the time of every database update. Please feel free to consult us about detailed conditions and circumstances.

[Target databases]

JADER, FAERS, VAERS, CAERS, etc.

*JADER (Japanese Adverse Drug Event Report database): a public database administrated by the PMDA containing adverse event reports.
*FAERS (FDA’s Adverse Event Reporting System): a public database administrated by the FDA containing adverse event reports, medication error reports and product quality complaints resulting
*CAERS (CFSAN Adverse Event Reporting System): a public database administrated by the FDA containing information such as adverse events and product complaint reports for foods, dietary supplements and cosmetics
*VAERS (Vaccine Adverse Event Reporting System): a public database administrated by the FDA containing post-vaccination adverse event report information

Analysis support

In addition to providing a signal score report, we perform contracted analysis using SRS data and other data.
We will examine your desired conditions, such as index, and proceed with analysis.
We are able to conduct analysis using RWD other than SRS data by utilizing the health insurance claims data and other sources including various databases held by JMIRI of our affiliate company.

[Target databases]

JADER, FAERS, VAERS, CAERS, etc.

*JADER (Japanese Adverse Drug Event Report database): a public database administrated by the PMDA containing adverse event reports.
*FAERS (FDA’s Adverse Event Reporting System): a public database administrated by the FDA containing adverse event reports, medication error reports and product quality complaints resulting
*CAERS (CFSAN Adverse Event Reporting System): a public database administrated by the FDA containing information such as adverse events and product complaint reports for foods, dietary supplements and cosmetics
*VAERS (Vaccine Adverse Event Reporting System): a public database administrated by the FDA containing post-vaccination adverse event report information

[Analysis case: Changes in the number of spontaneous reports]

• Objective: To grasp the changes before and after the COVID-19 outbreak
• Database: FAERS/JADER
• Results: Signal indicators and the number of adverse events were calculated.

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Joint research/independent research

<2017>

1. “Unknown/known classification of spontaneous reports of adverse events by comprehensive mapping technology of adverse drug reaction terms”
   The 20th Annual Meeting of the Japanese Society of Drug Informatics
2. “Construction of automatic classification system for unknown/known of spontaneous reports of adverse events by comprehensive mapping of adverse drug reaction terms and its verification by SGLT2”
   The 27th Annual Meeting of the Japanese Society of Pharmaceutical Health Care and Sciences
3. “Integration of the spontaneous reporting database of adverse events, adverse drug reactions in package inserts and RMP safety specifications, and development of the periodic signal monitoring system"
   The 23rd Annual Meeting of the Japanese Society for Pharmacoepidemiology

<2018>
　Joint research) Comparison of the risk of acute pancreatitis between corticosteroids using the FAERS database
　The 21st Annual Meeting of the Japanese Society of Drug Informatics

1. Verification of the risk of urinary tract infection associated with SGLT2 inhibitors based on the health insurance claim database and spontaneous report database
   The 24th Annual Meeting of the Japanese Society for Pharmacoepidemiology
2. Investigation of the risk of upper respiratory tract infection with DPP-4 inhibitors using medical databases (health insurance claims/spontaneous reports)
   The 28th Annual Meeting of the Japanese Society of Pharmaceutical Health Care and Sciences

<2019>

1. Association between diabetes treatment and urinary tract infections: An analysis using data from the JMDC claims databaseJoint hosting with the 25th Annual Meeting of the Japanese Society for Pharmacoepidemiology and the ISPE’s 12th Asian Conference on Pharmacoepidemiology (ACPE)