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Table 1 Data Source Inclusion Criteria for Eligibility and Definitions of Relatedness for Evaluability

From: Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children

Data Source (Eligible)
 National Poison Data System (NPDS) • NPDS is the data repository of records of exposures to pharmaceutical and non-pharmaceutical substances reported to all regional poison centers located throughout the United States.
• Cases were defined as those that reported a medical outcome of moderate effect, major effect, or death.
 Food and Drug Administration Adverse Event Reporting System (FAERS) • FAERS is the database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA.
• Fatal and non-fatal serious adverse events based upon the International Conference on Harmonisation (ICH) definition
 English Language Medical Literature • Published scientific reports in abstract or full paper form.
• Cases were defined as those that met minimum eligibility criteria.
 Participating Manufacturer Postmarket Safety Databases • Medication error or accident records reported to drug manufacturers via postmarket surveillance requirements
• Fatal and non-fatal serious adverse events based upon the International Conference on Harmonisation (ICH) definition
 News/Media Reports • News and media reports indexed from an aggregate database of > 32,000 sources of headline information
• Cases were defined as those that met minimum eligibility criteria.
Definitions of Relatedness (Evaluable)a
 Related • History of ingestion consistent with exposure
• Drug levels consistent with exposure, if available
• Clinical course consistent with exposure
• No other cause of death/event evident
 Potentially Related • History of ingestion consistent with exposure
• Drug levels consistent with exposure, if available
• Clinical course consistent with exposure
• Other cause of death/event unlikely
• Drug may have been secondary cause of death/event
 Unlikely Related • No history of ingestion
• Drug levels inconsistent with exposure
• Clinical course inconsistent with exposure
• Other cause of death/event possible
 Unable to Determine if Related • Not enough case detail to evaluate relationship of drug to death/event
  1. aThe definitions of each relatedness category include the general characteristics of that definition. Cases meeting that definition are not required to have all defined characteristics