Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT03786094
Status:
TERMINATED
Last Update Posted:
2023-11-01
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}}}}, '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': 'C490954', 'term': 'eribulin'}, {'id': 'C000624271', 'term': 'balixafortide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@spexisbio.com', 'phone': '+41 61 567 16 00', 'title': 'Christian Zwingelstein', 'organization': 'Spexis AG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial was halted early due to failure to meet the primary endpoint.'}}, 'adverseEventsModule': {'timeFrame': '5 months', 'description': 'For the purposes of the clinical study report, a treatment-emergent adverse event (TEAE) was considered to have occurred at a similar rate between treatment arms if the percentage difference between arms was \\<5.0%. TEAEs were defined as AEs that occurred at or after administration of the first dose of any study treatment and through 30 days after the last dose of any study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Balixafortide + Eribulin', 'description': 'Balixafortide: Balixafortide + Eribulin', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 214, 'seriousNumAtRisk': 218, 'deathsNumAffected': 17, 'seriousNumAffected': 62}, {'id': 'EG001', 'title': 'Eribulin Monotherapy', 'description': 'Eribulin: Eribulin alone', 'otherNumAtRisk': 204, 'deathsNumAtRisk': 204, 'otherNumAffected': 197, 'seriousNumAtRisk': 204, 'deathsNumAffected': 13, 'seriousNumAffected': 54}], 'otherEvents': [{'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 62}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 68}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Neutropenic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Breast cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Lymphadenopathy mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Immune-mediated pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Malignant gastrointestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Oesophageal compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Chronic inflammatory demyelinating polyradiculoneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Tumour associated fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Acute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}, {'term': 'Lens extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (2nd Line+ Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Balixafortide + Eribulin', 'description': 'Balixafortide: Balixafortide + Eribulin'}, {'id': 'OG001', 'title': 'Eribulin Monotherapy', 'description': 'Eribulin: Eribulin alone'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.2'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '4.3'}]}]}], 'analyses': [{'pValue': '0.4450', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '96', 'paramValue': '1.10', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.41', 'estimateComment': 'HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.', 'description': 'To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.\n\nPFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Population (2nd Line+)'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (3rd Line+ Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Balixafortide + Eribulin', 'description': 'Balixafortide: Balixafortide + Eribulin'}, {'id': 'OG001', 'title': 'Eribulin Monotherapy', 'description': 'Eribulin: Eribulin alone'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.2'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '4.2'}]}]}], 'analyses': [{'pValue': '0.6158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '96', 'paramValue': '1.07', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.41', 'estimateComment': 'HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.', 'description': 'To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.\n\nPFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3rd Line+ Population'}, {'type': 'SECONDARY', 'title': 'Overall Survival (3rd Line+ Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Balixafortide + Eribulin', 'description': 'Balixafortide: Balixafortide + Eribulin'}, {'id': 'OG001', 'title': 'Eribulin Monotherapy', 'description': 'Eribulin: Eribulin alone'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '12.3'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '14.0'}]}]}], 'analyses': [{'pValue': '0.6126', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.9', 'paramValue': '1.08', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.77', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'The Investigator monitored the patient for OS status every 6 months (or more frequently) until: death, the patient withdrew consent to follow-up for survival, or until the patient was lost to follow-up (whichever occurred first).', 'description': 'To compare the overall survival (OS) between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm. OS is defined as the time from date of randomization to date of death due to any cause. Patients who are lost to follow-up or are not known to have died at the time of data-cut-off for analysis or who do not have any follow up since randomization were censored.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3rd Line+ Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Balixafortide + Eribulin', 'description': 'Balixafortide: Balixafortide + Eribulin\n\nBalixafortide was administered as a single IV administration (5.5 mg/kg over at least 2 hours \\[±10 minutes\\]) on Days 1-3 and Days 8-10 of each 21-day cycle. Eribulin was administered IV at a dose of 1.4 mg/m2 over 2 to 5 minutes on Days 2 and 9 of each 21-day cycle.'}, {'id': 'FG001', 'title': 'Eribulin Monotherapy', 'description': 'Eribulin was administered as a single IV administration (1.4 mg/m2 over 2-5 minutes) on Days 2 and 9 of each 21-day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '213'}]}, {'type': 'Overall Population (2nd Line+)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '213'}]}, {'type': '3rd Line+ Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '202'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Balixafortide + Eribulin', 'description': 'Balixafortide: Balixafortide + Eribulin'}, {'id': 'BG001', 'title': 'Eribulin Monotherapy', 'description': 'Eribulin: Eribulin alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '10.87', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '11.07', 'groupId': 'BG001'}, {'value': '55.0', 'spread': '10.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '28', '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': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Breast Cancer History', 'classes': [{'title': 'Time since first diagnosis of breast cancer', 'categories': [{'measurements': [{'value': '6.99', 'spread': '6.096', 'groupId': 'BG000'}, {'value': '7.21', 'spread': '5.647', 'groupId': 'BG001'}, {'value': '7.10', 'spread': '5.873', 'groupId': 'BG002'}]}]}, {'title': 'Time since diagnosis of locally recurrent or metastatic disease', 'categories': [{'measurements': [{'value': '2.96', 'spread': '2.503', 'groupId': 'BG000'}, {'value': '3.15', 'spread': '2.427', 'groupId': 'BG001'}, {'value': '3.05', 'spread': '2.464', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Overall Population (2nd Line+)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-15', 'size': 3008556, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-13T11:33', 'hasProtocol': True}, {'date': '2021-05-14', 'size': 2835515, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-13T11:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 432}}, 'statusModule': {'whyStopped': 'The study was halted early due to failure to meet the primary endpoint.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2018-12-20', 'resultsFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2018-12-20', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-30', 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (2nd Line+ Population)', 'timeFrame': 'Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.', 'description': 'To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.\n\nPFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).'}, {'measure': 'Progression Free Survival (3rd Line+ Population)', 'timeFrame': 'Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.', 'description': 'To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.\n\nPFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (3rd Line+ Population)', 'timeFrame': 'The Investigator monitored the patient for OS status every 6 months (or more frequently) until: death, the patient withdrew consent to follow-up for survival, or until the patient was lost to follow-up (whichever occurred first).', 'description': 'To compare the overall survival (OS) between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm. OS is defined as the time from date of randomization to date of death due to any cause. Patients who are lost to follow-up or are not known to have died at the time of data-cut-off for analysis or who do not have any follow up since randomization were censored.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer', 'Locally Recurrent Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Histologically confirmed Breast cancer\n* Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally recurrent breast cancer\n* refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy\n* At least 14 days from the completion of any previous cancer therapy\n* Adequate organ function\n* Life expectancy of 3 months or more\n* Willing and able to comply with the protocol and able to understand and willing to sign an informed consent\n\nKey Exclusion Criteria:\n\n* Previously treated with eribulin\n* Peripheral neuropathy Grade ≥3\n* Receipt of prior CXCR4 therapy\n* Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or sargramostim, or radiation therapy within 14 days prior to study Day 1\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to balixafortide or eribulin or other agents used in the study\n* Breast feeding or pregnant\n* Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, known congenital long QT syndrome, QT interval corrected with Fridericia's formula (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently taking drugs at known risk of prolonging the QT interval or causing torsades de pointes"}, 'identificationModule': {'nctId': 'NCT03786094', 'acronym': 'FORTRESS', 'briefTitle': 'Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spexis AG'}, 'officialTitle': 'An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'POL6326-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Eribulin', 'interventionNames': ['Drug: Eribulin']}, {'type': 'EXPERIMENTAL', 'label': 'Balixafortide + Eribulin', 'interventionNames': ['Drug: Eribulin', 'Drug: Balixafortide']}], 'interventions': [{'name': 'Eribulin', 'type': 'DRUG', 'otherNames': ['Eribulin Injection [Halaven]'], 'description': 'Eribulin alone', 'armGroupLabels': ['Balixafortide + Eribulin', 'Eribulin']}, {'name': 'Balixafortide', 'type': 'DRUG', 'otherNames': ['POL6326'], 'description': 'Balixafortide + Eribulin', 'armGroupLabels': ['Balixafortide + Eribulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Associates for Research and Excellence', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Mount Zion Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center South Bay', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '06856', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwalk Hospital', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists SOUTH - 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