Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT03414658
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2017-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-20', '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': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'C000609138', 'term': 'avelumab'}, {'id': 'C577122', 'term': 'utomilumab'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Adrienne_Waks@dfci.harvard.edu', 'phone': '617-632-3800', 'title': 'Adrienne G. Waks, MD', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks.', 'description': 'A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).', 'eventGroups': [{'id': 'EG000', 'title': 'NH: Trastuzumab + Vinorelbine', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 10, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 45, 'seriousNumAtRisk': 45, 'deathsNumAffected': 23, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab', 'description': "* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n* Utomilumab is administered intravenously once per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein\n\nUtomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells", 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 34, 'seriousNumAtRisk': 34, 'deathsNumAffected': 20, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ear and labyrinth disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Endocrine disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eyelid function disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Colonic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gastrointestinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Oral dysesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Edema face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'General disorders and administration site conditions - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neck edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hepatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Autoimmune disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Immune system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Papulopustular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rhinitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Radiation recall reaction (dermatologic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'CD4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cholesterol high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Investigations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Serum amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Metabolism and nutrition disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Musculoskeletal and connective tissue disorder - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nervous system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Psychiatric disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Renal and urinary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nipple deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Reproductive system and breast disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Uterine obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vaginal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Postnasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sleep apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Voice alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Body odor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bullous dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nail loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Palmar-plantar erythrodysesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin/subcutaneous tissue disorders; Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'seriousEvents': [{'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Obstruction gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Serum amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gallbladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NH: Trastuzumab + Vinorelbine', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.'}, {'id': 'OG001', 'title': 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein'}, {'id': 'OG002', 'title': 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab', 'description': "* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n* Utomilumab is administered intravenously once per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein\n\nUtomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells"}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '3.9'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5.5'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.53', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.81', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.32', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.14', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.64', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'description': 'Progression Free Survival is defined from the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST 1.1 or death from any cause, whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NH: Trastuzumab + Vinorelbine', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.'}, {'id': 'OG001', 'title': 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein'}, {'id': 'OG002', 'title': 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab', 'description': "* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n* Utomilumab is administered intravenously once per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein\n\nUtomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells"}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '31'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '32.3'}, {'value': '11.8', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '24.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Objective Response Rate is determined by Complete Response or Partial Response by RECIST 1.1. Per RECIST 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'percent of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NH: Trastuzumab + Vinorelbine', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.'}, {'id': 'OG001', 'title': 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein'}, {'id': 'OG002', 'title': 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab', 'description': "* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n* Utomilumab is administered intravenously once per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein\n\nUtomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells"}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Values are NA due to insufficient number of participants with events: only 2 patients had response in NH arm. The DOR of them are 4 and 10.3 months.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '25.2'}, {'value': '4.2', 'comment': '90% UCL could not be estimated due to insufficient number of participants with event.', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 years', 'description': 'Duration of Response is measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Per RECIST 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had response.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NH: Trastuzumab + Vinorelbine', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.'}, {'id': 'OG001', 'title': 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein'}, {'id': 'OG002', 'title': 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab', 'description': "* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n* Utomilumab is administered intravenously once per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein\n\nUtomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells"}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'comment': '90% UCL could not be estimated due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': 'NA'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '15.9', 'upperLimit': '36.1'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '17.3', 'upperLimit': '33.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 years', 'description': 'Overall survival is defined as the time from randomization to death from any cause, or is censored at date last known alive.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NH: Trastuzumab + Vinorelbine', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.'}, {'id': 'FG001', 'title': 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein'}, {'id': 'FG002', 'title': 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab', 'description': "* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n* Utomilumab is administered intravenously once per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein\n\nUtomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'AVIATOR enrolled 100 patients in 16 centers in the US between June 21, 2018 and March 1, 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'NH: Trastuzumab + Vinorelbine', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.'}, {'id': 'BG001', 'title': 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein'}, {'id': 'BG002', 'title': 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab', 'description': "* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n* Utomilumab is administered intravenously once per cycle\n\nVinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread\n\nTrastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.\n\nAvelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein\n\nUtomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells"}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '60'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '60'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '63'}, {'value': '54', 'groupId': 'BG003', 'lowerLimit': '46', 'upperLimit': '61'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ECOG PS', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}, {'title': '1', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The ECOG Performance Status Scale is a measurement used to assess how cancer impacts a patient\'s daily living abilities. Smaller grades are considered better outcomes, eg. grade 0 means "fully active, able to carry on all pre-disease performance without restriction."', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'groupId': 'BG000', 'lowerLimit': '20.9', 'upperLimit': '29.7'}, {'value': '24.9', 'groupId': 'BG001', 'lowerLimit': '23.1', 'upperLimit': '27.8'}, {'value': '26.4', 'groupId': 'BG002', 'lowerLimit': '23.7', 'upperLimit': '29.3'}, {'value': '25.2', 'groupId': 'BG003', 'lowerLimit': '22.5', 'upperLimit': '29.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-27', 'size': 976066, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-20T08:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2017-11-10', 'resultsFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-22', 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '2 years', 'description': 'Progression Free Survival is defined from the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST 1.1 or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '2 years', 'description': 'Objective Response Rate is determined by Complete Response or Partial Response by RECIST 1.1. Per RECIST 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}, {'measure': 'Duration of Response', 'timeFrame': '3 years', 'description': 'Duration of Response is measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Per RECIST 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions.'}, {'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'Overall survival is defined as the time from randomization to death from any cause, or is censored at date last known alive.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This research study is studying a combination of drugs as a possible treatment for breast cancer.\n\nThe drugs involved in this study are:\n\n* Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine)\n* Group B: Trastuzumab + Vinorelbine + Avelumab\n* Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)', 'detailedDescription': 'This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease. "Investigational" means that drug combination is being studied.\n\nThe FDA (the U.S. Food and Drug Administration) has not approved Utomilumab as a treatment for any disease.\n\nThe FDA (the U.S. Food and Drug Administration) has approved Avelumab as a treatment for other diseases.\n\nThe FDA (the U.S. Food and Drug Administration) has approved trastuzumab as a treatment option for this disease.\n\nThe FDA (the U.S. Food and Drug Administration) has approved vinorelbine as a treatment for other diseases and is commonly used as a treatment option for this disease.\n\nThe immune system is the body\'s natural defense against disease. The immune system sends a type of cells called T cells throughout the body to detect and fight infections and diseases-including cancers. One way the immune system controls the activity of T cells is through the PD-1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1 pathway and this stops T cells from attacking cancer cells. Avelumab is a type of drug, known as an antibody which is designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells. An antibody is a protein produced by the body\'s immune system when it detects harmful substances. Previous studies show that the administration of antibodies which block the PD-1 pathway can lead to tumor destruction.\n\nUtomilumab is an antibody designed to stimulate the body\'s immune system to fight cancer cells. Previous studies have shown that the administration of this type of antibody may help to prevent tumors from growing.\n\nIn the laboratory, adding avelumab and Utomilumab to trastuzumab appears to improve effectiveness. It is not known whether this is true in humans.\n\nIn this research study, the investigators are evaluating the activity of 3 different combinations: (a)trastuzumab and vinorelbine combined, (b) trastuzumab, vinorelbine and avelumab combined, and (c) trastuzumab, vinorelbine, avelumab and utomilumab combined in participants with metastatic HER2- positive breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years or older\n* Histologically confirmed breast adenocarcinoma that is unresectable loco-regionally advanced or metastatic\n* HER2-positive (immunohistochemistry score 3+) or ERBB2- amplification (Ratio ERBB2/centromeres ≥ 2.0 or mean gene copy number ≥ 6) on primary tumor or of metastatic or unresectable loco-regional biopsy.\n* Measurable disease per RECIST v1.1 (see Section 11)\n* Patients must have previous treatment with ado-trastuzumab emtansine (Kadcyla, T-DM1) in any setting. Patients must have previously received trastuzumab and pertuzumab in the metastatic setting or within 12 months of neoadjuvant/adjuvant treatment.\n* Patient must have progressed on their most recent line of therapy. Progression must have been demonstrated by radiological or clinical assessment.\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* Willingness and availability to submit FFPE tissue for central confirmation of HER2 positivity and central assessment of PD-L1 status. This can be from archival tissue from unresectable loco-regional or metastatic disease obtained ≤ 1 year prior to enrollment or new tissue material from a recently obtained surgical or diagnostic biopsy. Tissue obtained for the biopsy must not have been previously irradiated. If a patient does not have any available archival tissue ≤ 1 year old and the treating investigator does not feel that it would be safe to perform a fresh biopsy, the requirement for a fresh biopsy may be waived after discussion with the Principal Investigator.\n* Written informed consent for screening and trial participation procedures including biological material transfer and handling.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Hematopoietic status:\n\n * Absolute neutrophil count ≥ 1.0 × 109/L,\n * Platelet count ≥ 100 × 109/L,\n * Hemoglobin ≥ 9 g/dL\n* Hepatic status:\n\n * Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (\\< 2 × ULN) is allowed.\n * AST and ALT ≤ 2.5 × ULN; if the patient has liver metastases, ALT and AST must be ≤ 5 × ULN.\n* Renal status:\n\n * Creatinine ≤ 1.5 ×ULN or creatinine clearance \\> 60 ml/min\n * Proteinuria \\< 1 g/day\n* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulant.\n* If female of childbearing potential, must have a negative pregnancy test within 7 days of initiating treatment. Childbearing potential is defined by: those who have not been surgically sterilized and/or have had a menstrual period in the past year.\n* Participants of childbearing potential (as defined above) must be willing to use effective contraception during treatment and up to 7 months after stop of trial treatment. Acceptable methods of contraception are intrauterine devices, bilateral tubal occlusion, vasectomized, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.\n* Must not be breastfeeding/lactating.\n\nExclusion Criteria:\n\n* Prior therapy with any anti-PD-1, anti-PD-L1, L2, anti-4-1BB (CD137), or anti-CTLA4 therapy\n* Known Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)\n* Positive for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA \\[qualitative\\]).\n* History of interstitial lung disease\n* Active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically stable for at least 4 weeks before first dose of investigational product and do not require high-dose steroid treatment).\n* History of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association functional classification ≥3), angina, myocardial infarction or ventricular arrhythmia.\n* Previous severe hypersensitivity reaction to treatment with another monoclonal antibody.\n* Active infection requiring systemic therapy.\n* Chronic systemic therapy with immunosuppressive agents including corticosteroids.\n* Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the trial.\n* Concurrent disease or condition that would make the patient inappropriate for trial participation or any serious medical disorder that would interfere with the patient's safety.\n* No uncontrolled hypertension (≥180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen.\n* Chemotherapy, radiotherapy, and/or biological cancer therapy within 3 weeks prior to the first trial dose or has not recovered to CTCAE v.4 grade 1 or better from adverse events (except alopecia).\n* Unresolved or unstable, serious adverse events from prior administration of another investigational drug.\n* Live vaccines within 30 days prior to the first dose of trial therapy and during trial treatment."}, 'identificationModule': {'nctId': 'NCT03414658', 'briefTitle': 'The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination With Avelumab or Avelumab and Utomilumab (41BB/CD137 Agonist), in Patients With HER2-positive Metastatic Breast Cancer Who Have Progressed on Prior Trastuzumab and Pertuzumab', 'orgStudyIdInfo': {'id': '17-455'}, 'secondaryIdInfos': [{'id': 'TBCRC045', 'type': 'OTHER', 'domain': 'TBCRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NH: Trastuzumab + Vinorelbine', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle', 'interventionNames': ['Drug: Vinorelbine', 'Drug: Trastuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab', 'interventionNames': ['Drug: Vinorelbine', 'Drug: Trastuzumab', 'Drug: Avelumab']}, {'type': 'EXPERIMENTAL', 'label': 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab', 'description': '* Trastuzumab is administered intravenously twice per cycle\n* Vinorelbine is administered intravenously 3 times per cycle\n* Avelumab is administered intravenously twice per cycle\n* Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab\n* Utomilumab is administered intravenously once per cycle', 'interventionNames': ['Drug: Vinorelbine', 'Drug: Trastuzumab', 'Drug: Avelumab', 'Drug: Utomilumab']}], 'interventions': [{'name': 'Vinorelbine', 'type': 'DRUG', 'description': 'work by interfering with cell division, which leaves the tumor unable to grow and spread', 'armGroupLabels': ['NH: Trastuzumab + Vinorelbine', 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'description': 'trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.', 'armGroupLabels': ['NH: Trastuzumab + Vinorelbine', 'NHA: Trastuzumab + Vinorelbine + Avelumab', 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab']}, {'name': 'Avelumab', 'type': 'DRUG', 'description': 'monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein', 'armGroupLabels': ['NHA: Trastuzumab + Vinorelbine + Avelumab', 'NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab']}, {'name': 'Utomilumab', 'type': 'DRUG', 'description': "Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells", 'armGroupLabels': ['NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599-7305', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Fred Hutchinson Cancer Care', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Adrienne Waks, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adrienne G. Waks', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Breast Cancer Research Foundation', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adrienne G. Waks', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}