{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.007105307,0.0007282707,0.001415247,0.0003329631,0.0004180466,0.0007896786,0.0004561133,0.0006419228,0.003583284],"category_scores_gemma":[0.004872901,0.0002705746,0.001487696,0.000280975,0.0003592555,0.0008425043,0.0004422943,0.001320805,0.0005817359],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0003772464,"about_ca_system_score_gemma":0.0008169226,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0001877409,"about_ca_topic_score_gemma":0.0004435851,"domain_scores_codex":[0.9982697,0.0008694822,0.0001660152,0.0001720426,0.0002677609,0.000255026],"domain_scores_gemma":[0.9960597,0.001073597,0.001576416,0.0004560625,0.0004040665,0.0004302335],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"nonrandomized_trial","study_design_scores_codex":[0.835549,0.01059391,0.04907633,0.0006414197,0.002697551,0.0003407942,0.0002219329,0.001468929,0.02261992,0.0002458228,0.003499811,0.07304454],"study_design_scores_gemma":[0.1527035,0.5535403,0.2601127,0.0001369779,0.003778284,0.0007600251,0.0001615455,0.002906682,0.01772608,0.0005698522,0.007512758,0.00009134346],"study_design_candidate":"nonrandomized_trial","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9912148,0.001222415,0.001711188,0.0001818701,0.00008315361,0.001415164,0.002364848,0.0001079162,0.001698722],"genre_scores_gemma":[0.9912246,0.0002605836,0.001724097,0.0002684311,0.00007506883,0.002002861,0.003336352,0.00002369578,0.001084344],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.007105307,"threshold_uncertainty_score":0.03757691,"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."}}