{"id":"W4212774905","doi":"10.1016/j.jcf.2022.02.003","title":"A Phase 3, open-label, 96-week trial to study the safety, tolerability, and efficacy of tezacaftor/ivacaftor in children ≥ 6 years of age homozygous for F508del or heterozygous for F508del and a residual function CFTR variant","year":2022,"lang":"en","type":"article","venue":"Journal of Cystic Fibrosis","topic":"Cystic Fibrosis Research Advances","field":"Medicine","cited_by":13,"is_retracted":false,"has_abstract":false,"ca_institutions":"BC Children's Hospital","funders":"Engineering and Physical Sciences Research Council; National Institute for Health and Care Research; NIHR Imperial Biomedical Research Centre; Vertex Pharmaceuticals; AbbVie; Cystic Fibrosis Trust; Cystic Fibrosis Foundation","keywords":"Ivacaftor; Tolerability; Medicine; Cystic fibrosis; Discontinuation; Adverse effect; Internal medicine; Clinical endpoint; Clinical trial; Cystic fibrosis transmembrane conductance regulator","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":[0.001719831,0.001895078,0.002778256,0.0004253013,0.0005661913,0.001136386,0.001258336,0.002253462,0.008189362],"category_scores_gemma":[0.001787179,0.0007701108,0.002146449,0.0004197462,0.001449806,0.001705227,0.0003893725,0.005675465,0.001941361],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0009730838,"about_ca_system_score_gemma":0.001755239,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001338322,"about_ca_topic_score_gemma":0.003414359,"domain_scores_codex":[0.9994024,0.0002146664,0.00002531013,0.0001551543,0.00005537603,0.0001470691],"domain_scores_gemma":[0.9984179,0.0003543016,0.0003173173,0.0001705266,0.00008690715,0.0006530755],"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":[0.9220481,0.0316282,0.001684918,0.0003968113,0.0007833469,0.0001592018,0.0001736232,0.0009492474,0.01210641,0.0002587102,0.002425181,0.02738623],"study_design_scores_gemma":[0.8586924,0.1354576,0.003456857,0.00002534417,0.0001399886,0.0001501879,0.00003455397,0.0004857531,0.0006712139,0.000153217,0.0007081131,0.00002480923],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9874495,0.002302419,0.00107088,0.0006389272,0.0002788255,0.003453599,0.002583998,0.0002766686,0.001945042],"genre_scores_gemma":[0.979968,0.001761615,0.003539774,0.001325631,0.0002667492,0.005817463,0.003251485,0.00009259444,0.003976727],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.008189362,"threshold_uncertainty_score":0.02739608,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.05493126610839461,"score_gpt":0.3762085119645562,"score_spread":0.3212772458561616,"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."}}