{"id":"b81ad636-5541-5fa8-ace4-179849de11fe","stable_key":"5d8e27d8-6a74-5560-827f-3f90908bbc34:ala-sydney2-adverse-events","predicate":"dose_increases","statement":"Nausea, vomiting and vertigo increased with dose in SYDNEY 2.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"d9a0f07d-410d-561e-8d7b-b860871268c0","mechanism_event_label":"Higher studied doses did not simply mean a better tolerated response.","subject":{"id":"ab091982-3acb-5a87-80fb-85dfe292c1e0","slug":"lipoic-acid","display_name":"Lipoic acid","entity_type_key":"small_molecule"},"object":{"id":"da143c82-7f65-5d2f-94c1-f8dbbc4d7950","slug":"ala-gastrointestinal-adverse-events","display_name":"Gastrointestinal adverse events during lipoic-acid exposure","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"d9a0f07d-410d-561e-8d7b-b860871268c0","stable_key":"5d8e27d8-6a74-5560-827f-3f90908bbc34:ala-sydney2-adverse-events-event","event_type":"observed_intervention","label":"Higher studied doses did not simply mean a better tolerated response.","description":"Nausea, vomiting and vertigo increased with dose in SYDNEY 2.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"ab091982-3acb-5a87-80fb-85dfe292c1e0","slug":"lipoic-acid","display_name":"Lipoic acid","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"da143c82-7f65-5d2f-94c1-f8dbbc4d7950","slug":"ala-gastrointestinal-adverse-events","display_name":"Gastrointestinal adverse events during lipoic-acid exposure","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/ala-research/17065669.abstract.txt\", \"locator\": \"Exact primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"3a54016cad3453fec96e99aa5906435793d7baaddaf5254d5ce335aac5bb4519\", \"start_char\": 0, \"end_char\": 1756, \"text_sha256\": \"3a54016cad3453fec96e99aa5906435793d7baaddaf5254d5ce335aac5bb4519\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"SYDNEY 2 randomized double-blind placebo-controlled trial","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Oral ALA 600, 1200 or 1800 mg/day for five weeks","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Short-term symptom endpoint; no proof of nerve regeneration, lifelong benefit or correction of a nutritional deficiency.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Alpha-lipoic acid research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"lipoic-acid","display_name":"Lipoic acid","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"Human","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Higher studied doses did not simply mean a better tolerated response.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[ala-p17065669] Oral treatment with alpha-lipoic acid improves symptomatic diabetic polyneuropathy: the SYDNEY 2 trial. 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