safetyreportid,receivedate,serious,seriousnessdeath,seriousnesslifethreatening,seriousnesshospitalization,patientagegroup,patientsex,patientweight,patientonsetage,patientonsetageunit,reaction,drug,outcome,reportercountry,qualification,transmissiondate,therapeutic_area
17221355,2020-01-01,1,1,1,1,,2,,62,801,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Acute myeloid leukaemia, 'reactionoutcome': 5}]","[{'drugcharacterization': 1, 'medicinalproduct': EPIRUBICIN MYLAN, 'drugauthorizationnumb': NULL, 'drugstructuredosagenumb': 1, 'drugstructuredosageunit': 032, 'drugdosagetext': NULL, 'drugadministrationroute': 041, 'drugindication': BREAST CANCER, 'drugenddateformat': 610, 'drugenddate': 201506, 'actiondrug': 1, 'drugadditional': NULL, 'activesubstance': {'activesubstancename': EPIRUBICIN}, 'openfda': NULL, 'drugseparatedosagenumb': 1, 'drugintervaldosageunitnumb': 1, 'drugintervaldosagedefinition': 811, 'drugdosageform': SOLUTION FOR INFUSION, 'drugstartdateformat': 610, 'drugstartdate': 201504, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': NULL, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}, {'drugcharacterization': 1, 'medicinalproduct': PACLITAXEL ARROW, 'drugauthorizationnumb': NULL, 'drugstructuredosagenumb': 1, 'drugstructuredosageunit': 032, 'drugdosagetext': CONCENTRATED SOLUTION INFUSION, 'drugadministrationroute': 041, 'drugindication': BREAST CANCER, 'drugenddateformat': 610, 'drugenddate': 201508, 'actiondrug': 1, 'drugadditional': NULL, 'activesubstance': {'activesubstancename': PACLITAXEL}, 'openfda': NULL, 'drugseparatedosagenumb': 1, 'drugintervaldosageunitnumb': 1, 'drugintervaldosagedefinition': 811, 'drugdosageform': NULL, 'drugstartdateformat': 610, 'drugstartdate': 201506, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': NULL, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}, {'drugcharacterization': 1, 'medicinalproduct': 'ENDOXAN 1000 MG, POUDRE POUR SOLUTIONINJECTABLE', 'drugauthorizationnumb': 012142, 'drugstructuredosagenumb': 1, 'drugstructuredosageunit': 032, 'drugdosagetext': NULL, 'drugadministrationroute': 041, 'drugindication': BREAST CANCER, 'drugenddateformat': 610, 'drugenddate': 201506, 'actiondrug': 1, 'drugadditional': NULL, 'activesubstance': {'activesubstancename': CYCLOPHOSPHAMIDE}, 'openfda': NULL, 'drugseparatedosagenumb': 1, 'drugintervaldosageunitnumb': 1, 'drugintervaldosagedefinition': 811, 'drugdosageform': POWDER FOR SOLUTION FOR INJECTION, 'drugstartdateformat': 610, 'drugstartdate': 201504, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': NULL, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}]",,FR,1,2020-04-09,Oncology
17221374,2020-01-01,1,,,,,2,62,58,801,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Febrile neutropenia, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Anaemia, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Neuropathy peripheral, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Alopecia, 'reactionoutcome': 6}]","[{'drugcharacterization': 1, 'medicinalproduct': CARBOPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION, 'drugauthorizationnumb': 205487, 'drugstructuredosagenumb': 700, 'drugstructuredosageunit': 003, 'drugdosagetext': '700 MILLIGRAM, CYCLICAL', 'drugadministrationroute': 042, 'drugindication': MALIGNANT PERITONEAL NEOPLASM, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 2, 'drugadditional': NULL, 'activesubstance': {'activesubstancename': CARBOPLATIN}, 'openfda': NULL, 'drugseparatedosagenumb': NULL, 'drugintervaldosageunitnumb': NULL, 'drugintervaldosagedefinition': NULL, 'drugdosageform': CONCENTRATE FOR SOLUTION FOR INFUSION, 'drugstartdateformat': 102, 'drugstartdate': 20190820, 'drugrecurreadministration': 3, 'drugcumulativedosagenumb': 700, 'drugcumulativedosageunit': 003, 'drugbatchnumb': NULL, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}, {'drugcharacterization': 1, 'medicinalproduct': PACLITAXEL CONCENTRATE FOR SOLUTION FOR INFUSION, 'drugauthorizationnumb': NULL, 'drugstructuredosagenumb': 300, 'drugstructuredosageunit': 003, 'drugdosagetext': '300 MILLIGRAM, CYCLICAL', 'drugadministrationroute': 042, 'drugindication': MALIGNANT PERITONEAL NEOPLASM, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 2, 'drugadditional': NULL, 'activesubstance': {'activesubstancename': PACLITAXEL}, 'openfda': NULL, 'drugseparatedosagenumb': NULL, 'drugintervaldosageunitnumb': NULL, 'drugintervaldosagedefinition': NULL, 'drugdosageform': CONCENTRATE FOR SOLUTION FOR INFUSION, 'drugstartdateformat': 102, 'drugstartdate': 20190820, 'drugrecurreadministration': 3, 'drugcumulativedosagenumb': 300, 'drugcumulativedosageunit': 003, 'drugbatchnumb': NULL, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}]",,IT,1,2020-04-09,Oncology
17221376,2020-01-01,1,1,,,,2,,,,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Pancreatic carcinoma, 'reactionoutcome': 5}]","[{'drugcharacterization': 1, 'medicinalproduct': ENBREL, 'drugauthorizationnumb': 103795, 'drugstructuredosagenumb': NULL, 'drugstructuredosageunit': NULL, 'drugdosagetext': UNK, 'drugadministrationroute': 065, 'drugindication': PRODUCT USED FOR UNKNOWN INDICATION, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 6, 'drugadditional': NULL, 'activesubstance': {'activesubstancename': ETANERCEPT}, 'openfda': {'application_number': [BLA103795], 'brand_name': [ENBREL], 'generic_name': [ETANERCEPT], 'manufacturer_name': [Immunex Corporation], 'product_ndc': [58406-010, 58406-425, 58406-021, 58406-032, 58406-044, 58406-055], 'product_type': [HUMAN PRESCRIPTION DRUG], 'route': [SUBCUTANEOUS], 'substance_name': [ETANERCEPT], 'rxcui': [253014, 261105, 727757, 802652, 809158, 809159, 1653223, 1653225, 2182338, 2182340, 2392140, 2392142], 'spl_id': [de3ee3bd-0047-4365-a4c7-5786521a1649], 'spl_set_id': [a002b40c-097d-47a5-957f-7a7b1807af7f], 'package_ndc': [58406-425-41, 58406-425-34, 58406-424-01, 58406-910-01, 58406-021-01, 58406-021-04, 58406-021-96, 58406-032-01, 58406-032-04, 58406-032-96, 58406-032-90, 58406-010-01, 58406-010-04, 58406-010-96, 58406-044-01, 58406-044-04, 58406-044-96, 58406-044-24, 58406-044-90, 58406-055-01, 58406-055-04, 58406-055-96, 58406-055-90], 'unii': [OP401G7OJC], 'nui': [N0000175610, N0000175451], 'pharm_class_epc': ['Tumor Necrosis Factor Blocker [EPC]'], 'pharm_class_moa': ['Tumor Necrosis Factor Receptor Blocking Activity [MoA]'], 'pharm_class_cs': NULL, 'pharm_class_pe': NULL}, 'drugseparatedosagenumb': NULL, 'drugintervaldosageunitnumb': NULL, 'drugintervaldosagedefinition': NULL, 'drugdosageform': SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, 'drugstartdateformat': 602, 'drugstartdate': 2017, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': NULL, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}]",,BR,5,2020-04-09,Oncology
17221382,2020-01-01,1,,,1,,1,93,55,801,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Encephalopathy, 'reactionoutcome': 3}]","[{'drugcharacterization': 1, 'medicinalproduct': CLOMIPRAMINE HYDROCHLORIDE., 'drugauthorizationnumb': NULL, 'drugstructuredosagenumb': 75, 'drugstructuredosageunit': 003, 'drugdosagetext': '75 MILLIGRAM, ONCE A DAY', 'drugadministrationroute': 065, 'drugindication': NEURALGIA, 'drugenddateformat': 102, 'drugenddate': 20191104, 'actiondrug': 1, 'drugadditional': 2, 'activesubstance': {'activesubstancename': CLOMIPRAMINE HYDROCHLORIDE}, 'openfda': {'application_number': [ANDA208961, ANDA213219, ANDA212285, ANDA209294, ANDA211364, ANDA213897, ANDA211822, ANDA216440, NDA019906, ANDA074694, ANDA211767], 'brand_name': [CLOMIPRAMINE HYDROCHLORIDE, ANAFRANIL], 'generic_name': [CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CAPSULES], 'manufacturer_name': [Northstar Rx LLC., Micro Labs Limited, 'Rising Pharma Holdings, Inc.', 'Lupin Pharmaceuticals, 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17221529,2020-01-01,1,1,,,,1,,70,801,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Pancytopenia, 'reactionoutcome': 5}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Alanine aminotransferase increased, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Transaminases increased, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': B-lymphocyte count decreased, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Intentional product use issue, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Pulmonary mycosis, 'reactionoutcome': 5}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Off label use, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Blood bilirubin increased, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Hepatitis E, 'reactionoutcome': 6}]","[{'drugcharacterization': 2, 'medicinalproduct': 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17221623,2020-01-01,1,,,,,2,,75,801,"[{'reactionmeddraversionpt': 23.0, 'reactionmeddrapt': Tubulointerstitial nephritis, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 23.0, 'reactionmeddrapt': Immune-mediated nephritis, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 23.0, 'reactionmeddrapt': IgA nephropathy, 'reactionoutcome': 6}]","[{'drugcharacterization': 1, 'medicinalproduct': PEMBROLIZUMAB., 'drugauthorizationnumb': 125514, 'drugstructuredosagenumb': 200, 'drugstructuredosageunit': 003, 'drugdosagetext': '200 MILLIGRAM, Q3W (IN CYCLES)', 'drugadministrationroute': NULL, 'drugindication': NON-SMALL CELL LUNG CANCER, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 1, 'drugadditional': NULL, 'activesubstance': {'activesubstancename': PEMBROLIZUMAB}, 'openfda': {'application_number': [BLA125514], 'brand_name': [KEYTRUDA], 'generic_name': [PEMBROLIZUMAB], 'manufacturer_name': [Merck Sharp & Dohme LLC], 'product_ndc': [0006-3026, 0006-3029], 'product_type': 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17221632,2020-01-01,1,,,1,,2,80,78,801,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Skin exfoliation, 'reactionoutcome': 2}]","[{'drugcharacterization': 1, 'medicinalproduct': PERJETA, 'drugauthorizationnumb': 125409, 'drugstructuredosagenumb': 420, 'drugstructuredosageunit': 003, 'drugdosagetext': RECENT DOSE ON 05/NOV/2019, 'drugadministrationroute': 041, 'drugindication': BREAST CANCER RECURRENT, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 5, 'drugadditional': 3, 'activesubstance': {'activesubstancename': PERTUZUMAB}, 'openfda': {'application_number': [BLA125409], 'brand_name': [PERJETA], 'generic_name': [PERTUZUMAB], 'manufacturer_name': ['Genentech, Inc.'], 'product_ndc': [50242-145], 'product_type': [HUMAN PRESCRIPTION DRUG], 'route': [INTRAVENOUS], 'substance_name': [PERTUZUMAB], 'rxcui': [1298948, 1298953], 'spl_id': [dfebfe9c-a0c5-41d8-bf11-ed643627e264], 'spl_set_id': [17f85d17-ab71-4f5b-9fe3-0b8c822f69ff], 'package_ndc': [50242-145-01], 'unii': [K16AIQ8CTM], 'nui': [N0000175661, N0000020008], 'pharm_class_epc': ['HER2/neu Receptor Antagonist [EPC]'], 'pharm_class_moa': ['HER2/Neu/cerbB2 Antagonists [MoA]'], 'pharm_class_cs': NULL, 'pharm_class_pe': NULL}, 'drugseparatedosagenumb': 1, 'drugintervaldosageunitnumb': 3, 'drugintervaldosagedefinition': 803, 'drugdosageform': SOLUTION FOR INFUSION, 'drugstartdateformat': 102, 'drugstartdate': 20191014, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': UNKNOWN, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}, {'drugcharacterization': 1, 'medicinalproduct': PACLITAXEL ACCORD, 'drugauthorizationnumb': NULL, 'drugstructuredosagenumb': 147, 'drugstructuredosageunit': 003, 'drugdosagetext': RECENT DOSE ON 12/NOV/2019, 'drugadministrationroute': 041, 'drugindication': BREAST CANCER RECURRENT, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 5, 'drugadditional': 3, 'activesubstance': {'activesubstancename': PACLITAXEL}, 'openfda': NULL, 'drugseparatedosagenumb': 1, 'drugintervaldosageunitnumb': 1, 'drugintervaldosagedefinition': 803, 'drugdosageform': NULL, 'drugstartdateformat': 102, 'drugstartdate': 20191014, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': UNKNOWN, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}, {'drugcharacterization': 1, 'medicinalproduct': ONTRUZANT, 'drugauthorizationnumb': NULL, 'drugstructuredosagenumb': 486, 'drugstructuredosageunit': 003, 'drugdosagetext': RECENT DOSE ON 05/NOV/2019, 'drugadministrationroute': 041, 'drugindication': BREAST CANCER RECURRENT, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 5, 'drugadditional': 3, 'activesubstance': {'activesubstancename': TRASTUZUMAB-DTTB}, 'openfda': {'application_number': [BLA761100], 'brand_name': [ONTRUZANT], 'generic_name': [TRASTUZUMAB, ONTRUZANT], 'manufacturer_name': [Organon LLC], 'product_ndc': [78206-147, 78206-148], 'product_type': [HUMAN PRESCRIPTION DRUG], 'route': [INTRAVENOUS], 'substance_name': [TRASTUZUMAB], 'rxcui': [2289227, 2289232, 2289234, 2289237], 'spl_id': [9b665849-a59e-4da6-ae51-36b3c885b85b], 'spl_set_id': [ce2a2492-85e3-4b0a-872a-047f44e4203d], 'package_ndc': [78206-147-99, 78206-147-01, 78206-148-01, 78206-191-99, 78206-149-89], 'unii': [P188ANX8CK], 'nui': [N0000175661, N0000020008], 'pharm_class_epc': ['HER2/neu Receptor Antagonist [EPC]'], 'pharm_class_moa': ['HER2/Neu/cerbB2 Antagonists [MoA]'], 'pharm_class_cs': NULL, 'pharm_class_pe': NULL}, 'drugseparatedosagenumb': 1, 'drugintervaldosageunitnumb': 3, 'drugintervaldosagedefinition': 803, 'drugdosageform': NULL, 'drugstartdateformat': 102, 'drugstartdate': 20191014, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': UNKNOWN, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}]",,FR,1,2020-04-09,Oncology
17221685,2020-01-01,1,,,,,1,,,,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Neoplasm malignant, 'reactionoutcome': 6}]","[{'drugcharacterization': 1, 'medicinalproduct': ALECENSA, 'drugauthorizationnumb': 208434, 'drugstructuredosagenumb': NULL, 'drugstructuredosageunit': NULL, 'drugdosagetext': NULL, 'drugadministrationroute': NULL, 'drugindication': METASTASES TO CENTRAL NERVOUS SYSTEM, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 5, 'drugadditional': 3, 'activesubstance': {'activesubstancename': ALECTINIB HYDROCHLORIDE}, 'openfda': {'application_number': [NDA208434], 'brand_name': [ALECENSA], 'generic_name': [ALECTINIB HYDROCHLORIDE], 'manufacturer_name': ['Genentech, Inc.'], 'product_ndc': [50242-130], 'product_type': [HUMAN PRESCRIPTION DRUG], 'route': [ORAL], 'substance_name': [ALECTINIB HYDROCHLORIDE], 'rxcui': [1727479, 1727485], 'spl_id': [abdb3f90-4a44-4404-a49c-8d3bbc4dd13b], 'spl_set_id': [42c49deb-713b-427a-9670-08af08adcffb], 'package_ndc': [50242-130-01, 50242-130-86], 'unii': [P9YY73LO6J], 'nui': NULL, 'pharm_class_epc': NULL, 'pharm_class_moa': NULL, 'pharm_class_cs': NULL, 'pharm_class_pe': NULL}, 'drugseparatedosagenumb': NULL, 'drugintervaldosageunitnumb': NULL, 'drugintervaldosagedefinition': NULL, 'drugdosageform': NULL, 'drugstartdateformat': NULL, 'drugstartdate': NULL, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': 'UNKNOWN,UNKNOWN', 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}, {'drugcharacterization': 1, 'medicinalproduct': ALECENSA, 'drugauthorizationnumb': 208434, 'drugstructuredosagenumb': 600, 'drugstructuredosageunit': 003, 'drugdosagetext': NULL, 'drugadministrationroute': 048, 'drugindication': BRONCHIAL CARCINOMA, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 5, 'drugadditional': 3, 'activesubstance': {'activesubstancename': ALECTINIB HYDROCHLORIDE}, 'openfda': {'application_number': [NDA208434], 'brand_name': [ALECENSA], 'generic_name': [ALECTINIB HYDROCHLORIDE], 'manufacturer_name': ['Genentech, Inc.'], 'product_ndc': [50242-130], 'product_type': [HUMAN PRESCRIPTION DRUG], 'route': [ORAL], 'substance_name': [ALECTINIB HYDROCHLORIDE], 'rxcui': [1727479, 1727485], 'spl_id': [abdb3f90-4a44-4404-a49c-8d3bbc4dd13b], 'spl_set_id': [42c49deb-713b-427a-9670-08af08adcffb], 'package_ndc': [50242-130-01, 50242-130-86], 'unii': [P9YY73LO6J], 'nui': NULL, 'pharm_class_epc': NULL, 'pharm_class_moa': NULL, 'pharm_class_cs': NULL, 'pharm_class_pe': NULL}, 'drugseparatedosagenumb': 2, 'drugintervaldosageunitnumb': 1, 'drugintervaldosagedefinition': 804, 'drugdosageform': CAPSULE, 'drugstartdateformat': 102, 'drugstartdate': 20180201, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': 'UNKNOWN,UNKNOWN', 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}, {'drugcharacterization': 1, 'medicinalproduct': ALECENSA, 'drugauthorizationnumb': 208434, 'drugstructuredosagenumb': 150, 'drugstructuredosageunit': 003, 'drugdosagetext': 'TAKE 3 CAPSULE(S) BY MOUTH TWICE A DAY', 'drugadministrationroute': 048, 'drugindication': BRONCHIAL CARCINOMA, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 5, 'drugadditional': 3, 'activesubstance': {'activesubstancename': ALECTINIB HYDROCHLORIDE}, 'openfda': {'application_number': [NDA208434], 'brand_name': [ALECENSA], 'generic_name': [ALECTINIB HYDROCHLORIDE], 'manufacturer_name': ['Genentech, Inc.'], 'product_ndc': [50242-130], 'product_type': [HUMAN PRESCRIPTION DRUG], 'route': [ORAL], 'substance_name': [ALECTINIB HYDROCHLORIDE], 'rxcui': [1727479, 1727485], 'spl_id': [abdb3f90-4a44-4404-a49c-8d3bbc4dd13b], 'spl_set_id': [42c49deb-713b-427a-9670-08af08adcffb], 'package_ndc': [50242-130-01, 50242-130-86], 'unii': [P9YY73LO6J], 'nui': NULL, 'pharm_class_epc': NULL, 'pharm_class_moa': NULL, 'pharm_class_cs': NULL, 'pharm_class_pe': NULL}, 'drugseparatedosagenumb': NULL, 'drugintervaldosageunitnumb': NULL, 'drugintervaldosagedefinition': NULL, 'drugdosageform': CAPSULE, 'drugstartdateformat': NULL, 'drugstartdate': NULL, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': 'UNKNOWN,UNKNOWN', 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}]",,US,5,2020-04-09,Oncology
17221692,2020-01-01,1,,,,,1,,66,801,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Ejection fraction decreased, 'reactionoutcome': 1}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Cardiac failure, 'reactionoutcome': 1}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Weight increased, 'reactionoutcome': 1}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Dyspnoea, 'reactionoutcome': 1}]","[{'drugcharacterization': 1, 'medicinalproduct': ONCOVIN, 'drugauthorizationnumb': NULL, 'drugstructuredosagenumb': NULL, 'drugstructuredosageunit': NULL, 'drugdosagetext': 'STRENGTH: 1 MG / ML. 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17221875,2020-01-01,1,,,,,2,,58,801,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Interstitial lung disease, 'reactionoutcome': 2}]","[{'drugcharacterization': 1, 'medicinalproduct': HERCEPTIN, 'drugauthorizationnumb': 103792, 'drugstructuredosagenumb': NULL, 'drugstructuredosageunit': NULL, 'drugdosagetext': DOSAGE IS UNCERTAIN., 'drugadministrationroute': 041, 'drugindication': BREAST CANCER, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 1, 'drugadditional': 1, 'activesubstance': {'activesubstancename': TRASTUZUMAB}, 'openfda': {'application_number': [BLA103792], 'brand_name': [HERCEPTIN], 'generic_name': [TRASTUZUMAB], 'manufacturer_name': ['Genentech, Inc.'], 'product_ndc': [50242-132], 'product_type': [HUMAN PRESCRIPTION DRUG], 'route': [INTRAVENOUS], 'substance_name': [TRASTUZUMAB], 'rxcui': [1922509, 1922512], 'spl_id': [7517f775-6a10-4ddd-8dfb-6704ece413d0], 'spl_set_id': [492dbdb2-077e-4064-bff3-372d6af0a7a2], 'package_ndc': [50242-132-01], 'unii': 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'drugseparatedosagenumb': NULL, 'drugintervaldosageunitnumb': NULL, 'drugintervaldosagedefinition': NULL, 'drugdosageform': NULL, 'drugstartdateformat': NULL, 'drugstartdate': NULL, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': UNKNOWN, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}]",,JP,1,2020-04-09,Oncology
17221877,2020-01-01,1,,,,,2,117,54,801,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Deafness, 'reactionoutcome': 3}]","[{'drugcharacterization': 2, 'medicinalproduct': ESIDREX, 'drugauthorizationnumb': NULL, 'drugstructuredosagenumb': NULL, 'drugstructuredosageunit': NULL, 'drugdosagetext': NULL, 'drugadministrationroute': NULL, 'drugindication': NULL, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': NULL, 'drugadditional': NULL, 'activesubstance': {'activesubstancename': HYDROCHLOROTHIAZIDE}, 'openfda': NULL, 'drugseparatedosagenumb': NULL, 'drugintervaldosageunitnumb': NULL, 'drugintervaldosagedefinition': NULL, 'drugdosageform': NULL, 'drugstartdateformat': NULL, 'drugstartdate': NULL, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': UNKNOWN, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}, {'drugcharacterization': 1, 'medicinalproduct': HERCEPTIN, 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17221882,2020-01-01,1,1,,,,2,,44,801,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Wrong technique in product usage process, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Intentional product use issue, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Off label use, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Cerebrovascular accident, 'reactionoutcome': 5}]","[{'drugcharacterization': 1, 'medicinalproduct': ALECENSA, 'drugauthorizationnumb': 208434, 'drugstructuredosagenumb': NULL, 'drugstructuredosageunit': NULL, 'drugdosagetext': NULL, 'drugadministrationroute': 065, 'drugindication': LUNG NEOPLASM MALIGNANT, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 6, 'drugadditional': NULL, 'activesubstance': {'activesubstancename': ALECTINIB HYDROCHLORIDE}, 'openfda': {'application_number': [NDA208434], 'brand_name': [ALECENSA], 'generic_name': [ALECTINIB HYDROCHLORIDE], 'manufacturer_name': ['Genentech, Inc.'], 'product_ndc': [50242-130], 'product_type': [HUMAN PRESCRIPTION DRUG], 'route': [ORAL], 'substance_name': [ALECTINIB HYDROCHLORIDE], 'rxcui': [1727479, 1727485], 'spl_id': [abdb3f90-4a44-4404-a49c-8d3bbc4dd13b], 'spl_set_id': [42c49deb-713b-427a-9670-08af08adcffb], 'package_ndc': [50242-130-01, 50242-130-86], 'unii': [P9YY73LO6J], 'nui': NULL, 'pharm_class_epc': NULL, 'pharm_class_moa': NULL, 'pharm_class_cs': NULL, 'pharm_class_pe': NULL}, 'drugseparatedosagenumb': NULL, 'drugintervaldosageunitnumb': NULL, 'drugintervaldosagedefinition': NULL, 'drugdosageform': NULL, 'drugstartdateformat': NULL, 'drugstartdate': NULL, 'drugrecurreadministration': NULL, 'drugcumulativedosagenumb': NULL, 'drugcumulativedosageunit': NULL, 'drugbatchnumb': UNKNOWN, 'drugtreatmentduration': NULL, 'drugtreatmentdurationunit': NULL, 'drugrecurrence': NULL}]",,BR,1,2020-04-09,Oncology
17221917,2020-01-01,1,1,,,,,,,,"[{'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Leukopenia, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Vomiting, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Neutrophil count decreased, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Alanine aminotransferase increased, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Hyperuricaemia, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Cardiac arrest, 'reactionoutcome': 5}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Diarrhoea, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Nausea, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Thrombocytopenia, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Septic shock, 'reactionoutcome': 5}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Pancytopenia, 'reactionoutcome': 5}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Febrile neutropenia, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Sepsis, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Neutropenia, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Hyperglycaemia, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': White blood cell count decreased, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Pneumonia, 'reactionoutcome': 5}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Anaemia, 'reactionoutcome': 6}, {'reactionmeddraversionpt': 22.1, 'reactionmeddrapt': Platelet count decreased, 'reactionoutcome': 6}]","[{'drugcharacterization': 1, 'medicinalproduct': CYCLOPHOSPHAMIDE., 'drugauthorizationnumb': NULL, 'drugstructuredosagenumb': 750, 'drugstructuredosageunit': 009, 'drugdosagetext': NULL, 'drugadministrationroute': 042, 'drugindication': DIFFUSE LARGE B-CELL LYMPHOMA, 'drugenddateformat': NULL, 'drugenddate': NULL, 'actiondrug': 5, 'drugadditional': 3, 'activesubstance': {'activesubstancename': CYCLOPHOSPHAMIDE}, 'openfda': {'application_number': [ANDA218632, ANDA211757, ANDA211608, ANDA040745, NDA210852, ANDA215892, ANDA218282, NDA212501, ANDA210046, ANDA204555, ANDA218644, NDA012141, NDA203856, ANDA216783, ANDA214529, NDA210735, NDA217150, NDA217651], 'brand_name': [CYCLOPHOSPHAMIDE, FRINDOVYX], 'generic_name': [CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, 'CYCLOPHOSPHAMIDE INJECTION, SOLUTION'], 'manufacturer_name': ['Slate Run Pharmaceuticals, LLC', 'XGen Pharmaceuticals DJB, Inc.', Cipla USA Inc., 'Civica, Inc.', 'Avyxa Pharma, LLC', Alembic Pharmaceuticals Inc., 'OPKO Pharmaceuticals, LLC', 'Dr. Reddy\'s Labratories Inc.', Baxter Healthcare Company, Amneal Pharmaceuticals LLC, 'Fresenius Kabi USA, LLC', Sandoz Inc., BluePoint Laboratories, Baxter Healthcare Corporation, Hikma Pharmaceuticals USA Inc., 'Nexus Pharmaceuticals, LLC', Sagent Pharmaceuticals, Alembic Pharmaceuticals Limited, 'Epic Pharma, LLC', Eugia US LLC, 'Hainan Poly Pharm. 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