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