{"id":"99aa5301-411b-5529-bf97-314e3049d341","stable_key":"dc8975b1-95ff-5d9b-be17-a1c04610cca7:mo-ttm-human-safety","predicate":"associated_with","statement":"Reversible asymptomatic liver-enzyme increases occurred in 11/28 patients receiving at least 30 mg/day; seven patients had serious adverse events of mixed attribution.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"c52385a5-3ec6-592d-a830-e223a5bcb920","mechanism_event_label":"The drug results include adverse effects as well as copper reduction.","subject":{"id":"31872b9d-823f-59af-b080-3da93502fb6c","slug":"bis-choline-tetrathiomolybdate","display_name":"Bis-choline tetrathiomolybdate","entity_type_key":"small_molecule"},"object":{"id":"603fdfb3-d0c7-5fe5-9d2f-07368d34956c","slug":"serum-liver-enzyme-elevation","display_name":"Serum liver enzyme elevation","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"c52385a5-3ec6-592d-a830-e223a5bcb920","stable_key":"dc8975b1-95ff-5d9b-be17-a1c04610cca7:mo-ttm-human-safety-event","event_type":"observed_intervention","label":"The drug results include adverse effects as well as copper reduction.","description":"Reversible asymptomatic liver-enzyme increases occurred in 11/28 patients receiving at least 30 mg/day; seven patients had serious adverse events of mixed attribution.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"31872b9d-823f-59af-b080-3da93502fb6c","slug":"bis-choline-tetrathiomolybdate","display_name":"Bis-choline tetrathiomolybdate","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"603fdfb3-d0c7-5fe5-9d2f-07368d34956c","slug":"serum-liver-enzyme-elevation","display_name":"Serum liver enzyme elevation","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/molybdenum-research/28988934.abstract.txt\", \"locator\": \"Exact primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"6ca2c31c7a405be35fb18be79af77bbac1efc1dceb26a625f5a5cd35121cba7c\", \"start_char\": 0, \"end_char\": 3591, \"text_sha256\": \"6ca2c31c7a405be35fb18be79af77bbac1efc1dceb26a625f5a5cd35121cba7c\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Open-label phase 2 trial in 28 adults with Wilson disease","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"24 weeks of response-adjusted bis-choline tetrathiomolybdate","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"No blinded comparator. Pharmacological copper-binding drug, not nutritional molybdenum; endpoint corrects for drug-bound copper.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Molybdenum research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"molybdenum","display_name":"Molybdenum","entity_type_key":"nutrient_element"}},{"dimension":"organism","value_text":"Homo sapiens","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"The drug results include adverse effects as well as copper reduction.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[mo-p28988934] Bis-choline tetrathiomolybdate in patients with Wilson's disease: an open-label, multicentre, phase 2 study. 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Pharmacological copper-binding drug, not nutritional molybdenum; endpoint corrects for drug-bound copper.\nexposure: 24 weeks of response-adjusted bis-choline tetrathiomolybdate\nevidence_span: {\"source_cache\": \"artifacts/molybdenum-research/28988934.abstract.txt\", \"locator\": \"Exact primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"6ca2c31c7a405be35fb18be79af77bbac1efc1dceb26a625f5a5cd35121cba7c\", \"start_char\": 0, \"end_char\": 3591, \"text_sha256\": \"6ca2c31c7a405be35fb18be79af77bbac1efc1dceb26a625f5a5cd35121cba7c\"}\n[mo-p28988934] Bis-choline tetrathiomolybdate in patients with Wilson's disease: an open-label, multicentre, phase 2 study. 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