{"id":"W4408244205","doi":"10.1002/epi4.70015","title":"Interim analysis of the long‐term efficacy and safety of azetukalner in an ongoing open‐label extension study following a phase 2b clinical trial (X‐<scp>TOLE</scp>) in adults with focal epilepsy","year":2025,"lang":"en","type":"article","venue":"Epilepsia Open","topic":"Epilepsy research and treatment","field":"Medicine","cited_by":7,"is_retracted":false,"has_abstract":true,"ca_institutions":"Xenon Pharmaceuticals (Canada)","funders":"Thomas Jefferson University; Eisai; State University of New York Upstate Medical University; UCB Pharma; Sun Pharma; National Institute of Neurological Disorders and Stroke; NeuroPace; State University of New York; Harmony Biosciences; University of South Alabama; SK Life Science; Syracuse University","keywords":"Medicine; Adverse effect; Interim; Interim analysis; Pediatrics; Confidence interval; Clinical trial; Internal medicine; Anesthesia","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":[],"consensus_categories":[],"category_scores_codex":[0.003297312,0.0003298157,0.00198703,0.0006445494,0.0001179021,0.0001086945,0.0009516904,0.000156308,0.00002395299],"category_scores_gemma":[0.001403717,0.000208556,0.0002287886,0.002234624,0.0002148606,0.0003835358,0.001344505,0.0005995687,0.000001611108],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001392128,"about_ca_system_score_gemma":0.0005090749,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00158115,"about_ca_topic_score_gemma":0.008991173,"domain_scores_codex":[0.9950926,0.001272217,0.001662791,0.0009466252,0.0005543925,0.0004714142],"domain_scores_gemma":[0.9967685,0.001186983,0.0003785703,0.001253981,0.0001545185,0.0002574083],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.09195962,0.01958209,0.8602278,0.00006101849,0.001711322,0.0003498143,0.001705378,0.00001795847,0.0001507811,0.00002594001,0.00003493182,0.02417339],"study_design_scores_gemma":[0.2322459,0.01205325,0.7501068,0.001665713,0.001194087,0.000002883329,0.001461247,0.00101557,0.0001531267,0.00001193031,0.000008843626,0.00008062001],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9900751,0.0001700233,0.00005837181,0.0002649023,0.000128182,0.008488504,0.00002102901,0.00001072583,0.0007831684],"genre_scores_gemma":[0.9989006,0.00006416915,0.0003468832,0.0001174846,0.00003016668,0.0002482087,0.00006815017,0.00002784105,0.0001964934],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1402863,"threshold_uncertainty_score":0.8504667,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.09170532375274143,"score_gpt":0.4672422930781829,"score_spread":0.3755369693254414,"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."}}