{"id":"W2890474078","doi":"10.1186/s40164-018-0114-9","title":"Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy","year":2018,"lang":"en","type":"article","venue":"Experimental Hematology and Oncology","topic":"Neutropenia and Cancer Infections","field":"Medicine","cited_by":13,"is_retracted":false,"has_abstract":true,"ca_institutions":"Hydro One (Canada); Apotex (Canada)","funders":"","keywords":"Biosimilar; Pegfilgrastim; Medicine; Breast cancer; Equivalence (formal languages); Oncology; Internal medicine; Pharmacology; Medical physics; Filgrastim; Cancer; Granulocyte colony-stimulating factor; Chemotherapy; Mathematics","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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.0006764617,0.0003448398,0.001303766,0.000173439,0.0003040788,0.00002487609,0.0001136245,0.0003272858,0.00005496513],"category_scores_gemma":[0.0003555316,0.0002919709,0.00009250281,0.0002219447,0.0008254215,0.0001294791,0.00009072452,0.0002605658,0.000002443127],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001729572,"about_ca_system_score_gemma":0.0003140748,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00008133177,"about_ca_topic_score_gemma":0.000408548,"domain_scores_codex":[0.997255,0.0004240033,0.0008077403,0.0008890085,0.0001347739,0.0004894265],"domain_scores_gemma":[0.9980149,0.0007740095,0.0003255666,0.0002328093,0.0004271142,0.0002255564],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.7016794,0.009374785,0.2071505,0.0005922357,0.0008918872,0.00003642283,0.01040527,0.000001387478,0.05856176,0.0006424371,0.002982543,0.007681342],"study_design_scores_gemma":[0.6435283,0.03193617,0.1245325,0.0005697634,0.0008480268,0.0003420514,0.004168242,0.001639257,0.1890607,0.0001216113,0.00221316,0.001040081],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9851692,0.000244623,0.0002102459,0.004308858,0.0007461141,0.008999316,0.0001016902,0.00005336795,0.0001666039],"genre_scores_gemma":[0.9925267,0.0001078016,0.002834401,0.001618368,0.0001715154,0.002647173,0.00003882446,0.00003267044,0.00002256694],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.130499,"threshold_uncertainty_score":0.9999533,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.05775297218359463,"score_gpt":0.4161463259655735,"score_spread":0.3583933537819789,"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."}}