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"1367439" ], "spl_id": [ "254b26fa-28c4-4a9e-9df7-c9747829eaee", "10ea7737-88e0-4b3b-9741-d67fb521e3d1" ], "spl_set_id": [ "19ef66d1-913f-49a8-a0a5-59b4e20322f5", "55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d97" ], "package_ndc": [ "59212-146-01", "59212-146-03", "78206-146-01", "78206-146-03" ], "nui": [ "M0447349", "N0000175602", "N0000175825", "N0000000100" ], "pharm_class_cs": [ "Progesterone Congeners [CS]" ], "pharm_class_epc": [ "Progestin [EPC]", "Estrogen [EPC]" ], "pharm_class_moa": [ "Estrogen Receptor Agonists [MoA]" ], "unii": [ "304GTH6RNH", "423D2T571U" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20111012" } } }, { "safetyreportversion": "1", "safetyreportid": "10008749", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "2", "companynumb": "US-009507513-1403USA005223", "duplicate": "1", "reportduplicate": { "duplicatesource": "MERCK", "duplicatenumb": "US-009507513-1403USA005223" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hypertension", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "NUVARING", "drugauthorizationnumb": "021187", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 RING", "drugdosageform": "Vaginal Ring", "drugadministrationroute": "067", "actiondrug": "1", "openfda": { "application_number": [ "NDA021187" ], "brand_name": [ "NUVARING" ], "generic_name": [ "ETONOGESTREL AND ETHINYL ESTRADIOL" ], "manufacturer_name": [ "Advanz Pharma (US) Corp.", "Organon LLC" ], "product_ndc": [ "59212-146", "78206-146" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "VAGINAL" ], "substance_name": [ "ETONOGESTREL", "ETHINYL ESTRADIOL" ], "rxcui": [ "1367436", "1367439" ], "spl_id": [ "254b26fa-28c4-4a9e-9df7-c9747829eaee", "10ea7737-88e0-4b3b-9741-d67fb521e3d1" ], "spl_set_id": [ "19ef66d1-913f-49a8-a0a5-59b4e20322f5", "55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d97" ], "package_ndc": [ "59212-146-01", "59212-146-03", "78206-146-01", "78206-146-03" ], "nui": [ "M0447349", "N0000175602", "N0000175825", "N0000000100" ], "pharm_class_cs": [ "Progesterone Congeners [CS]" ], "pharm_class_epc": [ "Progestin [EPC]", "Estrogen [EPC]" ], "pharm_class_moa": [ "Estrogen Receptor Agonists [MoA]" ], "unii": [ "304GTH6RNH", "423D2T571U" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10010237", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140314", "fulfillexpeditecriteria": "2", "companynumb": "US-009507513-1403USA004800", "duplicate": "1", "reportduplicate": { "duplicatesource": "MERCK", "duplicatenumb": "US-009507513-1403USA004800" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "19", "patientonsetageunit": "801", "patientweight": "38.55", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Anxiety", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "NUVARING", "drugauthorizationnumb": "021187", "drugdosagetext": "UNK", "drugdosageform": "Vaginal Ring", "drugadministrationroute": "059", "drugstartdateformat": "102", "drugstartdate": "20140303", "actiondrug": "4", "openfda": { "application_number": [ "NDA021187" ], "brand_name": [ "NUVARING" ], "generic_name": [ "ETONOGESTREL AND ETHINYL ESTRADIOL" ], "manufacturer_name": [ "Advanz Pharma (US) Corp.", "Organon LLC" ], "product_ndc": [ "59212-146", "78206-146" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "VAGINAL" ], "substance_name": [ "ETONOGESTREL", "ETHINYL ESTRADIOL" ], "rxcui": [ "1367436", "1367439" ], "spl_id": [ "254b26fa-28c4-4a9e-9df7-c9747829eaee", "10ea7737-88e0-4b3b-9741-d67fb521e3d1" ], "spl_set_id": [ "19ef66d1-913f-49a8-a0a5-59b4e20322f5", "55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d97" ], "package_ndc": [ "59212-146-01", "59212-146-03", "78206-146-01", "78206-146-03" ], "nui": [ "M0447349", "N0000175602", "N0000175825", "N0000000100" ], "pharm_class_cs": [ "Progesterone Congeners [CS]" ], "pharm_class_epc": [ "Progestin [EPC]", "Estrogen [EPC]" ], "pharm_class_moa": [ "Estrogen Receptor Agonists [MoA]" ], "unii": [ "304GTH6RNH", "423D2T571U" ] } } ] } } ] }