{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 197 } }, "results": [ { "safetyreportversion": "3", "safetyreportid": "10085950", "primarysourcecountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140408", "receiptdateformat": "102", "receiptdate": "20140708", "fulfillexpeditecriteria": "1", "companynumb": "BTG00116", "duplicate": "1", "reportduplicate": { "duplicatesource": "BTG PHARM", "duplicatenumb": "BTG00116" }, "primarysource": { "reportercountry": "GB" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "84", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Drug ineffective" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Toxicity to various agents" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Bradycardia" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Atrioventricular block second degree" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Atrioventricular block complete" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "DIGIFAB", "drugauthorizationnumb": "103910", "drugdosagetext": "4 VIALS, SINGLE", "drugindication": "TOXICITY TO VARIOUS AGENTS", "drugstartdateformat": "102", "drugstartdate": "20140312", "activesubstance": { "activesubstancename": "OVINE DIGOXIN IMMUNE FAB" } }, { "drugcharacterization": "1", "medicinalproduct": "ATENOLOL (ATENOLOL)", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { 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