{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.003084611,0.0003444725,0.0006064146,0.00007075866,0.0006964377,0.00002167706,0.0001840396,0.000127946,0.0002086882],"category_scores_gemma":[0.003573981,0.0002482967,0.00009109417,0.0004002435,0.000371641,0.0001983846,0.0001841701,0.001149263,0.00004153468],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00008817939,"about_ca_system_score_gemma":0.0001119438,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00001779795,"about_ca_topic_score_gemma":0.00001302517,"domain_scores_codex":[0.9958034,0.0003737313,0.002272465,0.0006369183,0.0003580264,0.0005554164],"domain_scores_gemma":[0.9963276,0.0006377291,0.001590137,0.0002036232,0.0001291996,0.001111652],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"not_applicable","study_design_scores_codex":[0.01312596,0.001050954,0.2602055,0.006367718,0.003693583,0.004855209,0.05684642,0.006538004,0.291352,0.02482284,0.08289948,0.2482423],"study_design_scores_gemma":[0.004123437,0.0005541844,0.006438553,0.0002746274,0.00126703,0.0009808474,0.00863958,0.02542506,0.02956589,0.00005503336,0.9220743,0.0006014804],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.8709638,0.001766811,0.0007059941,0.1185547,0.001549841,0.001327419,0.00005952613,0.0003224575,0.004749503],"genre_scores_gemma":[0.9796595,0.0005048059,0.00009425014,0.01801551,0.001452181,0.0000857934,0.00002366957,0.00003028985,0.0001340044],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.8391748,"threshold_uncertainty_score":0.9999969,"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."}}