{"id":"W2986575254","doi":"10.1182/blood-2019-122980","title":"Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine","year":2019,"lang":"en","type":"article","venue":"Blood","topic":"Acute Myeloid Leukemia Research","field":"Medicine","cited_by":60,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Alberta; Queen Elizabeth II Health Sciences Centre; Ottawa Hospital; University of Ottawa; Princess Margaret Cancer Centre","funders":"","keywords":"Medicine; Decitabine; Pharmacokinetics; Adverse effect; Pharmacology; Dosing; Hypomethylating agent; Azacitidine; Tolerability; Bioavailability; Phases of clinical research; Population; Clinical endpoint; Bioequivalence; Cmax; Internal medicine; Nausea; Clinical trial","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":true,"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":[0.004655262,0.001063401,0.00186189,0.0003707621,0.000492763,0.001316926,0.0006924051,0.001467244,0.005958783],"category_scores_gemma":[0.003469848,0.0006204058,0.001838532,0.0003963029,0.001080862,0.001179092,0.000475376,0.003285437,0.0009969078],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0008323138,"about_ca_system_score_gemma":0.001075981,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0004757149,"about_ca_topic_score_gemma":0.0007035221,"domain_scores_codex":[0.9977163,0.001249136,0.0001861013,0.0003583783,0.0002321379,0.0002579026],"domain_scores_gemma":[0.997467,0.0007298751,0.0006724983,0.0003703096,0.0001939437,0.0005662741],"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":[0.918061,0.0412665,0.003385815,0.0002381671,0.001144003,0.00008225042,0.0001635695,0.000524839,0.01569885,0.0001571739,0.0007946742,0.01848319],"study_design_scores_gemma":[0.2552358,0.7227837,0.01359766,0.00001777305,0.001152106,0.0001301746,0.00005369627,0.0006411036,0.004149002,0.0002469513,0.001960188,0.00003184322],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9923895,0.000820483,0.001134381,0.0001872157,0.0001304219,0.002587989,0.001215142,0.0000706205,0.001464398],"genre_scores_gemma":[0.9924815,0.0004951573,0.001454739,0.0004472964,0.0001752636,0.001815193,0.001405904,0.0000277573,0.001697229],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.005958783,"threshold_uncertainty_score":0.02461964,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.03016931032872139,"score_gpt":0.3654661771086529,"score_spread":0.3352968667799315,"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."}}