{"id":"W3113526150","doi":"10.1016/j.eclinm.2020.100693","title":"Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997–2019): A qualitative analysis from the Southern Network on Adverse Reactions (SONAR)","year":2020,"lang":"en","type":"article","venue":"EClinicalMedicine","topic":"Pharmacovigilance and Adverse Drug Reactions","field":"Pharmacology, Toxicology and Pharmaceutics","cited_by":7,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Toronto","funders":"Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Cancer Institute; Food and Drug Administration; University of North Carolina at Chapel Hill; University of Texas MD Anderson Cancer Center; University of California; Università di Pisa; National Institutes of Health; University of Pennsylvania; University of Texas at San Antonio; Saint Louis University; Case Western Reserve University; Tulane University; Johns Hopkins University; Indiana University; Baylor University; University of Utah; Medical University of South Carolina; American Cancer Society; Stanford University; University of New Mexico; Health Sciences Center, University of Oregon; University of Miami; University of Melbourne; Université Pierre et Marie Curie; Yale University; Københavns Universitet; McGill University; U.S. Food and Drug Administration; University of Chicago","keywords":"Medicine; Drug reaction; Adverse effect; Sonar; Adverse drug reaction; Intensive care medicine; Drug; Medical emergency; Psychiatry; Pharmacology; Oceanography","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","insufficient_payload"],"consensus_categories":["insufficient_payload"],"category_scores_codex":[0.001458511,0.000436474,0.000833497,0.0001365058,0.0008015248,0.00002366527,0.0004363652,0.0003004893,0.001561379],"category_scores_gemma":[0.001201598,0.0003310783,0.000405288,0.0008516724,0.0007360187,0.0002008312,0.0001332972,0.00189123,0.001011006],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00009203336,"about_ca_system_score_gemma":0.0001223575,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001192231,"about_ca_topic_score_gemma":0.000842647,"domain_scores_codex":[0.9954436,0.001467556,0.001214837,0.0008979315,0.000413117,0.0005629533],"domain_scores_gemma":[0.991361,0.00657928,0.000728833,0.0004482536,0.000170766,0.0007118949],"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":[0.005911317,0.00114749,0.1908914,0.0000603362,0.008061818,0.000204785,0.0511198,0.01420949,0.001107427,0.0001944208,0.7228564,0.004235286],"study_design_scores_gemma":[0.004950219,0.0003698299,0.06210213,0.000164941,0.004991818,0.000003289656,0.03919904,0.000725938,0.0002545182,0.0009765433,0.885612,0.0006496999],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9042085,0.0002997747,0.0001250407,0.08882897,0.002020644,0.001026403,0.002514477,0.0002103495,0.0007658801],"genre_scores_gemma":[0.9183678,0.001037263,0.0001930198,0.07670753,0.001578969,0.0000965005,0.0005756019,0.000038316,0.001404974],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1627556,"threshold_uncertainty_score":0.9999141,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.120622390254287,"score_gpt":0.4545814927119916,"score_spread":0.3339591024577045,"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."}}