{"id":"W3010852553","doi":"10.1007/s40290-020-00329-w","title":"US Food and Drug Administration Safety Advisories and Reporting to the Adverse Event Reporting System (FAERS)","year":2020,"lang":"en","type":"article","venue":"Pharmaceutical Medicine","topic":"Pharmacovigilance and Adverse Drug Reactions","field":"Pharmacology, Toxicology and Pharmaceutics","cited_by":46,"is_retracted":false,"has_abstract":false,"ca_institutions":"University of British Columbia","funders":"Canadian Institutes of Health Research","keywords":"Adverse Event Reporting System; Food and drug administration; Adverse effect; Medicine; Drug; Food safety; Environmental health; Emergency medicine; Pharmacology","routes":{"ca_aff":true,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.02259462,0.001139287,0.001663258,0.008200706,0.001284708,0.003712856,0.002240312,0.003843467,0.02633298],"category_scores_gemma":[0.106617,0.0007464368,0.002062071,0.007263737,0.0007794797,0.001885653,0.001468904,0.00398992,0.01269512],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002867168,"about_ca_system_score_gemma":0.01519787,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01539451,"about_ca_topic_score_gemma":0.008883152,"domain_scores_codex":[0.9713032,0.00961176,0.006873548,0.001491938,0.009710562,0.001008933],"domain_scores_gemma":[0.8070846,0.04751614,0.04509468,0.01468462,0.08114378,0.00447627],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0008955348,0.0008544763,0.03555717,0.002002916,0.0005180546,0.0003077994,0.0002268092,0.001448835,0.003797287,0.009034003,0.6755273,0.2698298],"study_design_scores_gemma":[0.0008097459,0.0007796226,0.08687391,0.002185274,0.0006552602,0.001132815,0.0002134388,0.004793317,0.008193159,0.007666531,0.8864856,0.000211251],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"empirical","genre_scores_codex":[0.03246432,0.01854998,0.1038551,0.06136533,0.00898831,0.01801128,0.3242432,0.02187622,0.4106461],"genre_scores_gemma":[0.2173051,0.02736649,0.1752804,0.07696211,0.006662626,0.01752878,0.367134,0.002482402,0.1092781],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.02633298,"threshold_uncertainty_score":0.1194932,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2034564212299265,"score_gpt":0.4756487230022144,"score_spread":0.2721923017722879,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}