{"id":"bbe2a467-afb1-58bd-a964-d4a95103a0bc","stable_key":"fe6af7fc-7372-5c4f-9c2f-2bbf56695397:phosphorus-burosumab-pain-null","predicate":"has_no_significant_adjusted_effect","statement":"Worst pain and physical function did not achieve significance after the trial’s multiplicity adjustment.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"b39201d7-3210-5f0b-8494-0b9d382e24d6","mechanism_event_label":"Not every symptom endpoint showed a reliable benefit.","subject":{"id":"065e5ba3-c727-542d-8509-073417902590","slug":"burosumab","display_name":"Burosumab anti-FGF23 antibody","entity_type_key":"protein"},"object":{"id":"afe5bb72-a4c8-57e9-b43c-21bcfb3749e7","slug":"xlh-worst-pain","display_name":"Brief Pain Inventory worst-pain score in adults with XLH","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"b39201d7-3210-5f0b-8494-0b9d382e24d6","stable_key":"fe6af7fc-7372-5c4f-9c2f-2bbf56695397:phosphorus-burosumab-pain-null-event","event_type":"observed_intervention","label":"Not every symptom endpoint showed a reliable benefit.","description":"Worst pain and physical function did not achieve significance after the trial’s multiplicity adjustment.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"065e5ba3-c727-542d-8509-073417902590","slug":"burosumab","display_name":"Burosumab anti-FGF23 antibody","entity_type_key":"protein"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"afe5bb72-a4c8-57e9-b43c-21bcfb3749e7","slug":"xlh-worst-pain","display_name":"Brief Pain Inventory worst-pain score in adults with XLH","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/phosphorus-research/29947083.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"c1b305f00a7b9a569ccd197728d942ebbf55f9eaa164a95086d69a34608d3c4e\", \"start_char\": 0, \"end_char\": 2327, \"text_sha256\": \"c1b305f00a7b9a569ccd197728d942ebbf55f9eaa164a95086d69a34608d3c4e\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Randomized double-blind placebo-controlled phase 3 trial","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Burosumab 1 mg/kg or placebo every four weeks; week-24 analysis","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"FGF23-mediated inherited disease, not simple nutritional deficiency. Pain and function outcomes require multiplicity-adjusted interpretation.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Phosphorus research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"phosphorus","display_name":"Phosphorus","entity_type_key":"nutrient_element"}},{"dimension":"organism","value_text":"Human","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Not every symptom endpoint showed a reliable benefit.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[phosphorus-p29947083] A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial Evaluating the Efficacy of Burosumab, an Anti-FGF23 Antibody, in Adults With X-Linked Hypophosphatemia: Week 24 Primary Analysis. (2018). https://pubmed.ncbi.nlm.nih.gov/29947083/ DOI: 10.1002/jbmr.3475","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"134 symptomatic adults with X-linked hypophosphatemia","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"929f7b36-2359-5510-99b0-a07d1ce45d43","evidence_kind":"source_excerpt","locator":"Lines 1232-1243","start_line":1232,"end_line":1243,"excerpt":"### phosphorus-burosumab-pain-null\nWorst pain and physical function did not achieve significance after the trial’s multiplicity adjustment.\nCondition category: normal\nnutrient_topic: Phosphorus research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: Not every symptom endpoint showed a reliable benefit.\norganism: Human\ntissue_or_cell_type: 134 symptomatic adults with X-linked hypophosphatemia\nexperimental_model: Randomized double-blind placebo-controlled phase 3 trial\nlimitations: FGF23-mediated inherited disease, not simple nutritional deficiency. Pain and function outcomes require multiplicity-adjusted interpretation.\nexposure: Burosumab 1 mg/kg or placebo every four weeks; week-24 analysis\nevidence_span: {\"source_cache\": \"artifacts/phosphorus-research/29947083.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"c1b305f00a7b9a569ccd197728d942ebbf55f9eaa164a95086d69a34608d3c4e\", \"start_char\": 0, \"end_char\": 2327, \"text_sha256\": \"c1b305f00a7b9a569ccd197728d942ebbf55f9eaa164a95086d69a34608d3c4e\"}\n[phosphorus-p29947083] A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial Evaluating the Efficacy of Burosumab, an Anti-FGF23 Antibody, in Adults With X-Linked Hypophosphatemia: Week 24 Primary Analysis. 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