{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.00195693,0.0005008655,0.001872689,0.0003588126,0.0001459537,0.00008827427,0.000349988,0.0001062059,0.0003080593],"category_scores_gemma":[0.001282143,0.0004099676,0.000102379,0.0006695652,0.0001875627,0.0002356689,0.0006057558,0.000483687,0.00001285879],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00009002057,"about_ca_system_score_gemma":0.0001545291,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000805426,"about_ca_topic_score_gemma":0.00002605527,"domain_scores_codex":[0.9952043,0.0009351975,0.001155443,0.001058626,0.0010285,0.000617879],"domain_scores_gemma":[0.9960694,0.001793124,0.0002744954,0.0008866069,0.0003599566,0.0006163748],"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":[0.534907,0.03584479,0.1876747,0.0003741468,0.00261315,0.0007525149,0.02303745,0.0004571411,0.1996201,0.000003800777,0.0000738989,0.01464127],"study_design_scores_gemma":[0.7058315,0.01507699,0.2647381,0.0001902415,0.00126922,0.00004102125,0.003368663,0.005514422,0.003563254,0.000006047805,0.00002750509,0.0003730831],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9886454,0.001006257,0.00006415039,0.00008950095,0.000107858,0.009827082,0.00009111572,0.00007828353,0.00009035353],"genre_scores_gemma":[0.9974985,0.00005164619,0.001711409,0.00008602781,0.0001554961,0.0001934665,0.00005721909,0.00008219326,0.0001640429],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1960568,"threshold_uncertainty_score":0.9998352,"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."}}