{"id":"W2982996777","doi":"10.1182/blood-2019-123757","title":"An Individualized Risk Mitigation Approach for Safety: Experience from the Mosunetuzumab (CD20/CD3 Bispecific Antibody) Development Program in Relation to Neurotoxicity Risk","year":2019,"lang":"en","type":"article","venue":"Blood","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":4,"is_retracted":false,"has_abstract":true,"ca_institutions":"Roche (Canada); Jewish General Hospital","funders":"","keywords":"Medicine; Adverse effect; Cytokine release syndrome; Internal medicine; Clinical trial; Rituximab; CD20; Oncology; Antibody; Immunology; Chimeric antigen receptor; Immunotherapy; Cancer","routes":{"ca_aff":true,"ca_fund":false,"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":[0.0233138,0.0003678195,0.001132376,0.001666754,0.000327313,0.001692262,0.0008078338,0.0007813147,0.001272631],"category_scores_gemma":[0.03490913,0.0002395873,0.001611837,0.001450484,0.0004440564,0.0011202,0.001043361,0.00148949,0.0001625532],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002827145,"about_ca_system_score_gemma":0.006006917,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002935108,"about_ca_topic_score_gemma":0.00873627,"domain_scores_codex":[0.98862,0.007395296,0.001591587,0.0005229753,0.00169013,0.0001800271],"domain_scores_gemma":[0.9686764,0.02132665,0.005268677,0.0005607452,0.003623474,0.0005439814],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"observational","study_design_scores_codex":[0.0007523836,0.000113206,0.003436669,0.02558354,0.001314936,0.0001377955,0.0004460715,0.0008667909,0.0008866269,0.001610362,0.006094636,0.958757],"study_design_scores_gemma":[0.003600444,0.01197445,0.05888642,0.2435226,0.02436402,0.003947231,0.002597685,0.00350428,0.007821243,0.01149703,0.6279604,0.000324355],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"review","genre_gemma":"empirical","genre_scores_codex":[0.01862376,0.9651976,0.00244066,0.007883153,0.0001427534,0.0003514344,0.0002706199,0.00003218744,0.005057823],"genre_scores_gemma":[0.2347595,0.7433838,0.01230509,0.007542738,0.0003716893,0.0004942145,0.00046009,0.00003521382,0.0006475432],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.0233138,"threshold_uncertainty_score":0.1232967,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02149087881260859,"score_gpt":0.3128144969756654,"score_spread":0.2913236181630568,"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."}}