Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-27 @ 4:11 AM
Study NCT ID:
NCT01125566
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2010-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia', 'Croatia', 'Finland', 'Jordan', 'Norway', 'Saudi Arabia', 'United Arab Emirates']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077716', 'term': 'Afatinib'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.\\>", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The Data Monitoring Committee recommended termination of recruitment due to low likelihood of the study meeting its primary objectives.'}}, 'adverseEventsModule': {'timeFrame': 'From first administration of treatment within the trial until last administration of treatment within the trial, up to 76 months.', 'description': 'Treated set was used for reporting the other adverse event and serious adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Afatinib + Vinorelbine (AV)', 'description': 'Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter\\^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.', 'otherNumAtRisk': 337, 'deathsNumAtRisk': 337, 'otherNumAffected': 331, 'seriousNumAtRisk': 337, 'deathsNumAffected': 235, 'seriousNumAffected': 123}, {'id': 'EG001', 'title': 'Trastuzumab + Vinorelbine (TV)', 'description': 'Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m\\^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.', 'otherNumAtRisk': 169, 'deathsNumAtRisk': 169, 'otherNumAffected': 163, 'seriousNumAtRisk': 169, 'deathsNumAffected': 111, 'seriousNumAffected': 45}, {'id': 'EG002', 'title': 'AV Switched to TV', 'description': 'This group describes participants who discontinued AV treatment and switched to TV, provided they were without disease progression on AV, following data monitoring committee (DMC) recommendation to terminate recruitment on 26 April 2013.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 64, 'seriousNumAtRisk': 75, 'deathsNumAffected': 3, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 28}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 256}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 139}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 270}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemorrhagic ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Device related thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abscess intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Genital infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lymphangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Muscle disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fibroadenoma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Infected neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pericardial effusion malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tumour necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neurogenic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lung consolidation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sinus disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Breast operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Central venous catheterisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib + Vinorelbine (AV)', 'description': 'Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter\\^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.'}, {'id': 'OG001', 'title': 'Trastuzumab + Vinorelbine (TV)', 'description': 'Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m\\^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.49', 'groupId': 'OG000', 'lowerLimit': '3.55', 'upperLimit': '9.07'}, {'value': '5.55', 'groupId': 'OG001', 'lowerLimit': '3.55', 'upperLimit': '10.84'}]}]}], 'analyses': [{'pValue': '0.4224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.41', 'pValueComment': 'Two sided p-value was derived from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.', 'estimateComment': 'Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months', 'description': 'PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.\n\nOnly data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.\n\nProgression of disease was determined if at least 1 of the following criteria applied:\n\n* At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm\n* Appearance of 1 or more new lesions\n* Unequivocal progression of existing non-target lesions', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised set (RS): The randomised set included all participants who were randomised to receive treatment, whether treated or not.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib + Vinorelbine (AV)', 'description': 'Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter\\^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.'}, {'id': 'OG001', 'title': 'Trastuzumab + Vinorelbine (TV)', 'description': 'Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m\\^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.17', 'groupId': 'OG000', 'lowerLimit': '10.74', 'upperLimit': '39.52'}, {'value': '29.60', 'groupId': 'OG001', 'lowerLimit': '13.34', 'upperLimit': '43.99'}]}]}], 'analyses': [{'pValue': '0.0240', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.63', 'pValueComment': 'Two sided p-value from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.', 'estimateComment': 'Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.', 'groupDescription': 'Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months.', 'description': 'OS is defined as time from randomisation to death irrespective of the cause of the death.\n\nFor patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'RS including participants with available data for OS.'}, {'type': 'SECONDARY', 'title': 'Best RECIST Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib + Vinorelbine (AV)', 'description': 'Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter\\^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.'}, {'id': 'OG001', 'title': 'Trastuzumab + Vinorelbine (TV)', 'description': 'Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m\\^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.'}], 'classes': [{'title': 'Complete response (CR)', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Partial response (PR)', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}, {'value': '44.0', 'groupId': 'OG001'}]}]}, {'title': 'Stable disease (SD)', 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000'}, {'value': '26.8', 'groupId': 'OG001'}]}]}, {'title': 'Progressive Disease (PD)', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6431', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.090', 'ciLowerLimit': '0.756', 'ciUpperLimit': '1.572', 'estimateComment': 'The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours Afatinib.', 'groupDescription': 'Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months', 'description': 'Best RECIST assessment is defined as CR, PR, stable disease (SD), progressive disease (PD) or not evaluable by investigator (RECIST version 1.1).\n\nCR for target lesions (TL): Disappearance of all target lesions.\n\nCR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\\<10mm short axis).\n\nPR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.\n\nSD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.\n\nPD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RS including participants with available data for best RECIST assessment.'}, {'type': 'SECONDARY', 'title': 'Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib + Vinorelbine (AV)', 'description': 'Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter\\^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.'}, {'id': 'OG001', 'title': 'Trastuzumab + Vinorelbine (TV)', 'description': 'Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m\\^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000', 'lowerLimit': '0.410', 'upperLimit': '0.519'}, {'value': '47.0', 'groupId': 'OG001', 'lowerLimit': '0.393', 'upperLimit': '0.549'}]}]}], 'analyses': [{'pValue': '0.8829', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.029', 'ciLowerLimit': '0.707', 'ciUpperLimit': '1.496', 'estimateComment': 'The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours AV.', 'groupDescription': 'Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.'}], 'paramType': 'NUMBER', 'timeFrame': 'Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Until final data-base lock on 30 Jul 2018; Up to 95 months)', 'description': 'OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.\n\nComplete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\\<10mm short axis)\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.\n\nOther factors which add to the overall response of an imaging timepoint as PR are as below:-\n\n* CR in TL, but non-CR/Non-PD in NTL leads to PR\n* CR in TL, but not evaluated NTL leads to PR\n* PR in TL, but non-PD NTL or not all evaluated NTL leads to PR', 'unitOfMeasure': 'Percentage of participants (%)', 'reportingStatus': 'POSTED', 'populationDescription': 'RS including participants with available data for OR.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Afatinib + Vinorelbine (AV)', 'description': 'Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter\\^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.'}, {'id': 'FG001', 'title': 'Trastuzumab + Vinorelbine (TV)', 'description': 'Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m\\^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.'}, {'id': 'FG002', 'title': 'AV Switched to TV', 'description': 'This group describes participants who discontinued AV treatment and switched to TV, provided they were without disease progression on AV, following data monitoring committee (DMC) recommendation to terminate recruitment on 26 April 2013.'}], 'periods': [{'title': 'Patients Before the Switch (26Apr2013)', 'milestones': [{'type': 'STARTED', 'comment': 'Randomised', 'achievements': [{'groupId': 'FG000', 'numSubjects': '339'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive disease according to RECIST', 'reasons': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Worsening of underlying cancer disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Refused to continue taking medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other than listed above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Patients Who Switched From AV to TV', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '73'}]}], 'dropWithdraws': [{'type': 'Progressive disease according to RECIST', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '59'}]}, {'type': 'Refused to continue taking medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Worsening of underlying cancer disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Other than listed above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This was randomised, active-controlled, open-label, parallel-group, 2 arm (2:1 ratio) trial in participants with metastatic human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer failing one prior trastuzumab treatment.', 'preAssignmentDetails': 'Participants were treated in the study until disease progression, undue toxicity, or withdrawal of consent. The cut-off date for RECIST-based efficacy was 08 Jun 2013; a second analysis (primarily for assessing Overall Survival (OS)) contains all data until final database lock (30 Jul 2018).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Afatinib + Vinorelbine (AV)', 'description': 'Participants received oral treatment of film-coated Afatinib tablet at a starting dose of 40 milligram (mg) once daily and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/meter\\^2 (meter=m) on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days. For Afatinib, a protocol-defined dose-reduction scheme was to be followed if a participant experienced certain pre-specified adverse events. From 26 April 2013, any participant who had been randomised to the AV arm stopped treatment, had the option to switch to Trastuzamb + Vinorelbine.'}, {'id': 'BG001', 'title': 'Trastuzumab + Vinorelbine (TV)', 'description': 'Participants received an intravenous infusion of Trastuzumab 2 mg/kilogram (kg) weekly, following an initial loading dose of 4 mg/kg and weekly 10 minutes intravenous infusion of Vinorelbine 25 mg/m\\^2 on days 1, 8, 15, and 22 of each course. The treatment was administered in treatment courses of 28 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.8', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '52.2', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity data was not reported for this trial.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS): The TS included all randomised participantsbwho were documented to have taken at least 1 dose of study medication (i.e. afatinib, trastuzumab, or vinorelbine). One centre with 6 subjects was excluded from analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 508}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-04', 'studyFirstSubmitDate': '2010-05-10', 'resultsFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-05', 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months', 'description': 'PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.\n\nOnly data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.\n\nProgression of disease was determined if at least 1 of the following criteria applied:\n\n* At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm\n* Appearance of 1 or more new lesions\n* Unequivocal progression of existing non-target lesions'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months.', 'description': 'OS is defined as time from randomisation to death irrespective of the cause of the death.\n\nFor patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.'}, {'measure': 'Best RECIST Assessment', 'timeFrame': 'From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months', 'description': 'Best RECIST assessment is defined as CR, PR, stable disease (SD), progressive disease (PD) or not evaluable by investigator (RECIST version 1.1).\n\nCR for target lesions (TL): Disappearance of all target lesions.\n\nCR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\\<10mm short axis).\n\nPR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.\n\nSD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.\n\nPD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions.'}, {'measure': 'Objective Response (OR)', 'timeFrame': 'Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Until final data-base lock on 30 Jul 2018; Up to 95 months)', 'description': 'OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.\n\nComplete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\\<10mm short axis)\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.\n\nOther factors which add to the overall response of an imaging timepoint as PR are as below:-\n\n* CR in TL, but non-CR/Non-PD in NTL leads to PR\n* CR in TL, but not evaluated NTL leads to PR\n* PR in TL, but non-PD NTL or not all evaluated NTL leads to PR'}]}, 'conditionsModule': {'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '26822398', 'type': 'DERIVED', 'citation': 'Harbeck N, Huang CS, Hurvitz S, Yeh DC, Shao Z, Im SA, Jung KH, Shen K, Ro J, Jassem J, Zhang Q, Im YH, Wojtukiewicz M, Sun Q, Chen SC, Goeldner RG, Uttenreuther-Fischer M, Xu B, Piccart-Gebhart M; LUX-Breast 1 study group. Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): an open-label, randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):357-366. doi: 10.1016/S1470-2045(15)00540-9. Epub 2016 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Histologically confirmed diagnosis of HER2-overexpression breast cancer\n* Stage IV metastatic disease\n* Must have progressed on one prior trastuzumab treatment\n* no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)\n* Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer\n* Must have (archived) tumour tissue sample available for central re-assessment of HER2-status\n* At least one measurable lesion according to RECIST 1.1.\n* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .\n\nExclusion criteria:\n\n* Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab\n* Prior treatment with vinorelbine\n* Known pre-existing interstitial lung disease\n* Active brain metastases\n* History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.\n* Cardiac left ventricular function with resting ejection fraction of less than 50%.\n* Patients unable to comply with the protocol.\n* Any contraindications for therapy with vinorelbine or trastuzumab.\n* Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.\n* Use of any investigational drug within 4 weeks of randomisation.\n* Inadequate hepatic, renal and haematologic organ function'}, 'identificationModule': {'nctId': 'NCT01125566', 'briefTitle': 'LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment', 'orgStudyIdInfo': {'id': '1200.75'}, 'secondaryIdInfos': [{'id': '2009-015476-98', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: trastuzumab with vinorelbine', 'description': 'patients receive weekly intravenous infusion of trastuzumab and vinorelbine', 'interventionNames': ['Drug: trastuzumab', 'Drug: vinorelbine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm A: BIBW 2992 with vinorelbine', 'description': 'patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine', 'interventionNames': ['Drug: BIBW 2992', 'Drug: vinorelbine']}], 'interventions': [{'name': 'BIBW 2992', 'type': 'DRUG', 'description': 'patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management', 'armGroupLabels': ['Arm A: BIBW 2992 with vinorelbine']}, {'name': 'trastuzumab', 'type': 'DRUG', 'description': 'patients receive trastuzumab 2mg/kg intravenously every week', 'armGroupLabels': ['Arm B: trastuzumab with vinorelbine']}, {'name': 'vinorelbine', 'type': 'DRUG', 'description': 'patients receive vinorelbine 25mg/m² intravenously every week', 'armGroupLabels': ['Arm B: trastuzumab with vinorelbine']}, {'name': 'vinorelbine', 'type': 'DRUG', 'description': 'patients receive vinorelbine 25mg/m² intravenously every week', 'armGroupLabels': ['Arm A: BIBW 2992 with vinorelbine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ironwood Cancer and Research Centers', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Robert A. Moss MD, FACP, Inc', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Heritage Healthcare', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Care Associates Medical Group, Inc', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Hematology Oncology Medical Group, Inc', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Central Coast Medical Oncology Corporation', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'North Shore Cancer Research Associates', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '50701', 'city': 'Waterloo', 'state': 'Iowa', 'country': 'United States', 'facility': 'Cedar Valley Cancer Center', 'geoPoint': {'lat': 42.49276, 'lon': -92.34296}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Pro Health Care Associated', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '28806', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': "Hope Women's Cancer Center", 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Cancer Specialists Cancer Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'C1425AWC', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto Medico de Asistencia e Investigaciones S. A.', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1280AEB', 'city': 'Capital Federal', 'country': 'Argentina', 'facility': 'Hospital Britanico'}, {'zip': 'C1050AAK', 'city': 'Ciudad Autonoma de Bs As', 'country': 'Argentina', 'facility': 'Sanatorio de la Provodencia'}, {'zip': 'S2000DSK', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'Sanatorio Parque', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2444', 'city': 'Port Macquarie', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Port Macquarie Base Hospital (PMBH)', 'geoPoint': {'lat': -31.43084, 'lon': 152.90894}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': "St Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peninsula Haematology & Oncology', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3135', 'city': 'Ringwood East', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Maroondah Hospital', 'geoPoint': {'lat': -37.81667, 'lon': 145.25}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Mount Medical Centre', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Ordensklinikum Linz GmbH - Barmherzige Schwestern', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1100', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Kaiser Franz Josef Spital Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '230017', 'city': 'Grodno', 'country': 'Belarus', 'facility': 'Grodno Regional Clinical Hospital', 'geoPoint': {'lat': 53.62865, 'lon': 23.8942}}, {'zip': '220013', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Public Health Inst. Minsk City Clinical Oncology Dispensary', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '223040', 'city': 'Minsk Region', 'country': 'Belarus', 'facility': 'N. N. Alexandrov National Cancer Center of Belarus'}, {'zip': '210603', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Vitebsk Regional Clinical Oncology Dispensary', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Brussels - HOSP Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Edegem - UNIV UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Liège - HOSP St-Joseph', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '29308-014', 'city': 'Cachoeiro de Itapemirim', 'country': 'Brazil', 'facility': 'Centro de Pesquisas Clínicas em Oncología', 'geoPoint': {'lat': -20.84889, 'lon': -41.11278}}, {'zip': '80420-090', 'city': 'Curitiba', 'country': 'Brazil', 'facility': 'Hospital Santa Cruz', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '98700-000', 'city': 'Ijuí', 'country': 'Brazil', 'facility': 'Associacao Hospital de Caridade de Ijui', 'geoPoint': {'lat': -28.38778, 'lon': -53.91472}}, {'zip': '90035-001', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Associação Hospitalar Moinhos de Vento', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90050-170', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Irmandade da Santa Casa de Misericórdia de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90430-090', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Centro de Novos Tratamentos CliniOnco', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '20560-120', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto Nacional do Câncer - INCA', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '09060-650', 'city': 'Santo André', 'country': 'Brazil', 'facility': 'Faculdade de Medicina do ABC', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '01317-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro de Referência da Saude da Mulher-Hosp Perola Byington', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Agency - Vancouver', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'E1C 8X3', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Dr. Leon Richard Oncology Centre', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'N2G 1G3', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Grand River Regional Cancer Centre', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Notre-Dame du CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1S 4L8', 'city': 'Québec', 'country': 'Canada', 'facility': 'CHU de Quebec-Universite Laval Research Centre', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Temuco', 'country': 'Chile', 'facility': 'Instituto Clínico Oncológico del Sur - ICOS', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Cancer Hospital of Chinese Academy of Medical Science', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100032', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100071', 'city': 'Beijing', 'country': 'China', 'facility': '307 Hospital of PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '130021', 'city': 'Changchun', 'country': 'China', 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '350014', 'city': 'Fuzhou', 'country': 'China', 'facility': 'Fujian Provincial Tumor Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510060', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'country': 'China', 'facility': 'NanFang Hosptial', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '150081', 'city': 'Haerbin', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Harbin Medical University'}, {'zip': '310009', 'city': 'Hangzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310022', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '250012', 'city': 'Jinan', 'country': 'China', 'facility': 'Qilu Hospital, Shangdong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '210002', 'city': 'Nanjing', 'country': 'China', 'facility': 'the 81th Hospital of PLA', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200033', 'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300060', 'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '430022', 'city': 'Wuhan', 'country': 'China', 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '370 87', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Hospital Ceske Budejovice', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '775 20', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'General Faculty Hospital, Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '140 44', 'city': 'Prague', 'country': 'Czechia', 'facility': 'MEDICON a.s., Praha 4', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Oncology Centre- Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'zip': '11553', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'El Manial Specialized Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'HOP Amiens-Picardie Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CTR P Papin, Onco, Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'HOP Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33300', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CLI Bordeaux Nord Aquitaine', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CTR J Perrin, Onco, Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'HOP Victor Hugo', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '44202', 'city': 'Nantes', 'country': 'France', 'facility': 'CTR Catherine de Sienne', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'HOP Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51000', 'city': 'Reims', 'country': 'France', 'facility': 'INS Jean Godinot, Onco, Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'CTR Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'CTR René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '67065', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CTR Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen, AöR', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '53111', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Medizinisches Zentrum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '46236', 'city': 'Bottrop', 'country': 'Germany', 'facility': 'OnkoDok GbR', 'geoPoint': {'lat': 51.52392, 'lon': 6.9285}}, {'zip': '50931', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln (AöR)', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '50935', 'city': 'Cologne', 'country': 'Germany', 'facility': 'St. Elisabeth-Krankenhaus', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '94469', 'city': 'Deggendorf', 'country': 'Germany', 'facility': 'DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU', 'geoPoint': {'lat': 48.84085, 'lon': 12.96068}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'Kliniken Essen - Mitte gGmbH', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '31134', 'city': 'Hildesheim', 'country': 'Germany', 'facility': 'Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}, {'zip': '39108', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Magdeburg AöR', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '80337', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität München - Campus Innenstadt', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar der Technischen Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '26121', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Onkologische Praxis Oldenburg', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '18059', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Universitätsfrauenklinik am Klinikum Südstadt', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '42105', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Facharzt für Innere Medizin', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': '380016', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Gujarat Cancer and Research Institute', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '444606', 'city': 'Amravati', 'country': 'India', 'facility': 'Sujan Surgical Cancer Hospital', 'geoPoint': {'lat': 20.93333, 'lon': 77.75}}, {'zip': '560029', 'city': 'Bangalore', 'country': 'India', 'facility': 'KIDWAI memoraial Institute of oncology', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560068', 'city': 'Bengaluru', 'country': 'India', 'facility': 'Sri Venkateshwara Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '600018', 'city': 'Chennai', 'country': 'India', 'facility': 'Dr. Rai Memorial Cancer Centre', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '500 024', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Bibi General Hospital and Cancer Centre', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '700054', 'city': 'Kolkata', 'country': 'India', 'facility': 'Orchid Nursing Home', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'city': 'Maharagama', 'country': 'India', 'facility': 'Natinal Cancer Institute'}, {'zip': '440 010', 'city': 'Nagpur', 'country': 'India', 'facility': 'Central India Cancer Research Institute', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '422004', 'city': 'Nashik', 'country': 'India', 'facility': 'Curie Manavata Cancer centre', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '411001', 'city': 'Pune', 'country': 'India', 'facility': 'Jehangir Hospital Oncology Department', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411011', 'city': 'Pune', 'country': 'India', 'facility': 'K.E.M Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '530002', 'city': 'Visakhapatnam', 'country': 'India', 'facility': 'King George Hospital', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'city': 'Dubliin 9', 'country': 'Ireland', 'facility': 'Beaumont Hospital'}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "St James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "St Vincent's University Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center, Jerusalem 91031', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center Tel Hashomer', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '44124', 'city': 'Ferrara', 'country': 'Italy', 'facility': "Azienda Ospedaliera Universitaria Arcispedale Sant'Anna", 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Europeo di Oncologia', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '09042', 'city': 'Monserrato (CA)', 'country': 'Italy', 'facility': 'P.O. Monserrato', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}, {'zip': '259-1193', 'city': 'Kanagawa, Isehara', 'country': 'Japan', 'facility': 'Tokai University Hospital'}, {'zip': '537-8511', 'city': 'Osaka, Osaka', 'country': 'Japan', 'facility': 'Osaka Medical Center for Cancer and Cardiovascular Diseases'}, {'zip': '104-0045', 'city': 'Tokyo, Chuo-ku', 'country': 'Japan', 'facility': 'National Cancer Center Hospital'}, {'zip': '1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'P. Stradins Clinical Univ. Hospital, Oncology Clinic', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '1079', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Riga East Univ. Hospital, Oncology Centre', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Lebanon', 'country': 'Lebanon', 'facility': 'Hammoud Hospital University Medical Centre (HHUMC)'}, {'zip': '50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '08660', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'National Cancer Institute, Vilnius', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '06090', 'city': 'Colonia Centro', 'country': 'Mexico', 'facility': 'Hospital de Jesus', 'geoPoint': {'lat': 28.82333, 'lon': -111.94062}}, {'zip': '3318 AT', 'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Albert SchweitzerZiekenhuis', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '3651 BM', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Máxima Medisch Centrum, locatie Eindhoven', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '6162 BG', 'city': 'Geleen', 'country': 'Netherlands', 'facility': 'Zuyderland Medisch Centrum', 'geoPoint': {'lat': 50.97417, 'lon': 5.82917}}, {'zip': '6419 PC', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Zuyderland Medisch Centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '8025 BP', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Zwolle', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '84', 'city': 'Cusco', 'country': 'Peru', 'facility': 'Hospital Nacional Adolfo Guevara Velasco', 'geoPoint': {'lat': -13.53188, 'lon': -71.96701}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Clinica San Judas Tadeo', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Miraflores', 'country': 'Peru', 'facility': 'Instituto Oncologico Miraflores S.A.', 'geoPoint': {'lat': -12.11331, 'lon': -77.03274}}, {'city': 'Trujillo', 'country': 'Peru', 'facility': 'Clinica Peruano Americana de Trujillo', 'geoPoint': {'lat': -8.11599, 'lon': -79.02998}}, {'zip': '15-027', 'city': 'Bialystok', 'country': 'Poland', 'facility': "Bialystock's Oncology Center", 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '41-902', 'city': 'Bytom', 'country': 'Poland', 'facility': 'Wojewodzki Specialist Hospital No. 4, Bytom', 'geoPoint': {'lat': 50.34802, 'lon': 18.93282}}, {'zip': '80-211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'University Clinical Center, Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '93-513', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Provincial Specialist M. Kopernik Hospital', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-099', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Ziemia Lubelska Oncological Center, Lublin', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '10-513', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Oncology Centre of Olsztyn "KOPERNIK" Sp. z.o.o.', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '61-866', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '04 141', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Military Medical Institute', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '3000-075', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Instituto Português de Oncologia de Coimbra Francisco Gentil', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '3041-801', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'CHUC, EPE - CHC-Maternidade Bissaya Barreto', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1099-023', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'IPO Lisboa Francisco Gentil, EPE', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '420-451', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Hospitalar São João,EPE', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4200-072', 'city': 'Porto', 'country': 'Portugal', 'facility': 'IPO Porto Francisco Gentil, EPE', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '420029', 'city': "Kazan'", 'country': 'Russia', 'facility': 'St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '129128', 'city': 'Moscow', 'country': 'Russia', 'facility': 'N.A. Semashko Central Clinical Hospital, Moscow', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '390011', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'GUZ "Regional Clinical Oncology Dispensary"', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '191104', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Regional Clinical Oncology Dispensary', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '119228', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Johns Hopkins Singapore International Medical Center', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '085 01', 'city': 'Bardejov', 'country': 'Slovakia', 'facility': 'St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov', 'geoPoint': {'lat': 49.29175, 'lon': 21.27271}}, {'zip': '833 10', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'National Institute of Oncology, Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '058 01', 'city': 'Poprad', 'country': 'Slovakia', 'facility': 'POKO Policlinic Dept. of Clinical Oncology', 'geoPoint': {'lat': 49.06144, 'lon': 20.29798}}, {'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '2193', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'WCR CMJAH Clinical Trial Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2196', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Medical Oncology Centre of Rosebank', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '7570', 'city': 'Kraaifontein', 'country': 'South Africa', 'facility': 'GVI oncology Medi Clinic', 'geoPoint': {'lat': -33.84808, 'lon': 18.71723}}, {'zip': '6045', 'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Langenhoven Drive Oncology Centre', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': '0041', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Wilgers oncology', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '7700', 'city': 'Rondebosch, Cape Town', 'country': 'South Africa', 'facility': 'Rondebosch Oncology Centre'}, {'zip': '410-769', 'city': 'Goyang', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '35016', 'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario Insular - Materno Infantil', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Hospital Clínico de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de la Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Arnau de Vilanova', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '422002', 'city': 'Maharashtra', 'country': 'Sri Lanka', 'facility': 'Shatabdi Superspeciality Hospital'}, {'zip': '50006', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Chang-Hua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '81362', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'NCKUH', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10449', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipe Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Koo Foundation Sun Yet-Sen Cancer Center', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital(TaoYuan)', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital & Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'The Royal Marsden Hospital', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'SE18 4QH', 'city': 'Woolwich, London', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}