Viewing Study NCT02394795

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 1:20 PM

Ignite Modification Date: 2026-02-22 @ 4:50 AM

Study NCT ID: NCT02394795

Status: COMPLETED

Last Update Posted: 2023-11-01

First Post: 2015-03-16

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077544', 'term': 'Panitumumab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication.\n\nSite will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 60 months', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.', 'otherNumAtRisk': 404, 'deathsNumAtRisk': 404, 'otherNumAffected': 399, 'seriousNumAtRisk': 404, 'deathsNumAffected': 14, 'seriousNumAffected': 115}, {'id': 'EG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.', 'otherNumAtRisk': 407, 'deathsNumAtRisk': 407, 'otherNumAffected': 392, 'seriousNumAtRisk': 407, 'deathsNumAffected': 9, 'seriousNumAffected': 95}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 105}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 146}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 135}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 158}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 160}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 249}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 165}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 158}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 162}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 48}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 210}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 201}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 224}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 80}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 44}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 203}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 286}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 300}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Taste disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 94}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 31}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 80}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 48}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 301}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 38}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 57}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 76}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Rhegmatogenous retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Diaphragmatic hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Large intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Mechanical ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pneumatosis intestinalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Death', 'notes': 'The reasons of events are not determined because assessment findings were insufficient to specify the reason.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Implant site dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Sudden death', 'notes': 'The reasons of events are not determined because assessment findings were insufficient to specify the reason.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Primary biliary cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Anorectal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Muscle abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Renal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pneumothorax traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Stoma site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Stoma site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Urinary tract stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hyperammonaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 407, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J v24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'OS in Participants With Left-sided Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'OG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.85', 'groupId': 'OG000', 'lowerLimit': '34.10', 'upperLimit': '42.58'}, {'value': '34.30', 'groupId': 'OG001', 'lowerLimit': '30.92', 'upperLimit': '40.28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 60 months', 'description': 'OS was measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. The number analyzed is the number of participants with data available for analysis.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS) in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'OG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.24', 'groupId': 'OG000', 'lowerLimit': '32.03', 'upperLimit': '39.03'}, {'value': '31.28', 'groupId': 'OG001', 'lowerLimit': '29.27', 'upperLimit': '34.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 60 months', 'description': 'OS was measured as the time from the date of randomization to the date of death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) in Participants With Left-sided Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'OG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.70', 'groupId': 'OG000', 'lowerLimit': '12.65', 'upperLimit': '15.34'}, {'value': '13.24', 'groupId': 'OG001', 'lowerLimit': '11.40', 'upperLimit': '14.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 60 months', 'description': 'PFS was defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause. The left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. The number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'OG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.91', 'groupId': 'OG000', 'lowerLimit': '11.30', 'upperLimit': '13.63'}, {'value': '11.99', 'groupId': 'OG001', 'lowerLimit': '11.30', 'upperLimit': '13.47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 60 months', 'description': 'PFS was defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Response Rate (RR) in All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'OG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}], 'classes': [{'categories': [{'title': 'CR', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'PR', 'measurements': [{'value': '284', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}, {'title': 'SD', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}, {'title': 'PD', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 60 months', 'description': 'RR was defined as number of participants who achieve Complete Response (CR) and Partial Response (PR) as the best overall response per RECIST version 1.1.The best overall response was CR, followed by PR, stable disease (SD), progressive disease (PD), and not evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization., SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. The number analyzed is the number of participants with data available for analysis. RR was assessed in participants with evaluable lesions at baseline.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'OG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.86', 'groupId': 'OG000', 'lowerLimit': '10.51', 'upperLimit': '13.37'}, {'value': '10.74', 'groupId': 'OG001', 'lowerLimit': '9.46', 'upperLimit': '12.19'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 60 months', 'description': 'DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation. The number analyzed is the number of participants with data available for analysis. DOR was evaluated in participants with complete or partial response.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Treated With Curative Surgical Resection After Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'OG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 60 months', 'description': 'Curative surgical resection was defined as complete resection.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without measure protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'OG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '402', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 60 months', 'description': 'Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred in the treatment period after receiving the protocol treatment.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS): all patients who initiated the protocol treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'FG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '404'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '406'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '211'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '93'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 197 investigative sites in Japan from 29 May 2015 to 14 January 2022.', 'preAssignmentDetails': 'Participants with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer were enrolled and randomized to either the mFOLFOX6 + panitumumab arm (Group P) or mFOLFOX6 + bevacizumab arm (Group B) at 1:1 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '400', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '802', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group P; mFOLFOX6 + Panitumumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.'}, {'id': 'BG001', 'title': 'Group B; mFOLFOX6 + Bevacizumab Combination Therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '65 years old or over', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '470', 'groupId': 'BG002'}]}, {'title': '64 years old or less', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '400', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '802', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '400', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '802', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Primary Tumor Categorized by Location', 'classes': [{'categories': [{'title': 'Left side', 'measurements': [{'value': '312', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}, {'title': 'Right side', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reported data were number of participants with primary tumor location categorized by Left side, Right side, or the Other at the start of this study. Primary tumor site (left side/right side/other) defined as following. Left side: Single lesion or multiple lesions in the descending colon, sigmoid colon, rectosigmoid region, or rectum. Right side: Single lesion or multiple lesions in the cecum, ascending colon, or transverse colon. Other: Multiple primary tumors extending over the right and left sides.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History', 'classes': [{'categories': [{'title': 'Had No Medical History', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Had Medical History', 'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '638', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical Complications', 'classes': [{'categories': [{'title': 'Had No Medical Complications', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}, {'title': 'Had Medical Complications', 'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications.', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '328', 'groupId': 'BG000'}, {'value': '319', 'groupId': 'BG001'}, {'value': '647', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work; 2=ambulatory (\\>50 percent of waking hours), capable of all self-care but unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \\>50 percent of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of protocol treatment without major protocol deviation.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-05', 'size': 1603442, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-12T18:16', 'hasProtocol': True}, {'date': '2022-02-03', 'size': 1164838, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-12T18:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 823}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2015-03-16', 'resultsFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-12', 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS in Participants With Left-sided Tumors', 'timeFrame': 'Up to approximately 60 months', 'description': 'OS was measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum.'}, {'measure': 'Overall Survival (OS) in All Participants', 'timeFrame': 'Up to approximately 60 months', 'description': 'OS was measured as the time from the date of randomization to the date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) in Participants With Left-sided Tumors', 'timeFrame': 'Up to approximately 60 months', 'description': 'PFS was defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause. The left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum.'}, {'measure': 'Progression-Free Survival (PFS) in All Participants', 'timeFrame': 'Up to approximately 60 months', 'description': 'PFS was defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause.'}, {'measure': 'Response Rate (RR) in All Participants', 'timeFrame': 'Up to approximately 60 months', 'description': 'RR was defined as number of participants who achieve Complete Response (CR) and Partial Response (PR) as the best overall response per RECIST version 1.1.The best overall response was CR, followed by PR, stable disease (SD), progressive disease (PD), and not evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization., SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 60 months', 'description': 'DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier.'}, {'measure': 'Number of Participants Treated With Curative Surgical Resection After Chemotherapy', 'timeFrame': 'Up to approximately 60 months', 'description': 'Curative surgical resection was defined as complete resection.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAE)', 'timeFrame': 'Up to approximately 60 months', 'description': 'Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred in the treatment period after receiving the protocol treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic colorectal cancer, Panitumumab, mFOLFOX6, Bevacizumab'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '38347302', 'type': 'DERIVED', 'citation': 'Shitara K, Muro K, Watanabe J, Yamazaki K, Ohori H, Shiozawa M, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Mori I, Yamanaka K, Hihara M, Soeda J, Misumi T, Yamamoto K, Yamashita R, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Baseline ctDNA gene alterations as a biomarker of survival after panitumumab and chemotherapy in metastatic colorectal cancer. Nat Med. 2024 Mar;30(3):730-739. doi: 10.1038/s41591-023-02791-w. Epub 2024 Feb 12.'}, {'pmid': '37071094', 'type': 'DERIVED', 'citation': 'Watanabe J, Muro K, Shitara K, Yamazaki K, Shiozawa M, Ohori H, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Hihara M, Soeda J, Misumi T, Yamamoto K, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Panitumumab vs Bevacizumab Added to Standard First-line Chemotherapy and Overall Survival Among Patients With RAS Wild-type, Left-Sided Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2023 Apr 18;329(15):1271-1282. doi: 10.1001/jama.2023.4428.'}, {'pmid': '28237539', 'type': 'DERIVED', 'citation': 'Yoshino T, Uetake H, Tsuchihara K, Shitara K, Yamazaki K, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Yamanaka K, Iwasaki K, Soeda J, Hihara M, Yamanaka T, Ochiai A, Muro K. Rationale for and Design of the PARADIGM Study: Randomized Phase III Study of mFOLFOX6 Plus Bevacizumab or Panitumumab in Chemotherapy-naive Patients With RAS (KRAS/NRAS) Wild-type, Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2017 Jun;16(2):158-163. doi: 10.1016/j.clcc.2017.01.001. Epub 2017 Jan 24.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f6b60294db2bf003ab499d1', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.', 'detailedDescription': 'The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.\n\nThis study will enroll a total of approximately 800 participants (400 per group).\n\nParticipants will be randomized to either the mFOLFOX6 + panitumumab arm (Group P) or mFOLFOX6 + bevacizumab arm (Group B) at 1:1 ratio at the time of registration.\n\nGroup P and Group B treatment regimen shown below should be administered once every two weeks, following dose, schedule and route of administration.\n\nGroup P; mFOLFOX6 + panitumumab combination therapy, once every two weeks OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg\n\nGroup B; mFOLFOX6 + bevacizumab combination therapy, once every two weeks OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg\n\nThis trial is conducted by multicenter and is scheduled for 12 months as whole administration period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol.\n\n Investigator is those who participate in conducting a study and oversight the study duties at a site.\n2. Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment\n3. Aged ≥20 to \\<80 years at the time of informed consent\n4. Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)\n5. Patients with lesion(s) that can be evaluated. It is not essential to be evaluated the tumor according to the RECIST ver. 1.1.\n6. Patients who have not received chemotherapy for colorectal cancer. Patients who experience relapse more than 24 weeks (168 days) after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled. Patients who have received perioperative adjuvant chemotherapy including oxaliplatin are excluded.\n7. Patients classified as KRAS/NRAS wild-type by KRAS/NRAS testing. KRAS/NRAS test will be performed using the in vitro diagnostic listed in the National Health Insurance.\n\n Patients with no mutation in any of the codons shown below are considered wild type. It is not considered wild type if either of the codons are not evaluable or not tested.\n\n KRAS: EXON2 (codon 12, 13), EXON3 (codon 59, 61), EXON4 (codon 117, 146) NRAS：EXON2 (codon 12, 13), EXON3 (codon 59, 61), EXON4 (codon 117, 146)\n8. Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment\n\n * Neutrophil count ≥ 1.5×10\\^3/µL\n * Platelet count ≥ 1.0×10\\^4/µL\n * Hemoglobin ≥ 9.0 g/dL\n * Total bilirubin ≤ 2.0 mg/dL\n * AST ≤ 100 IU/L (≤ 200 IU/L if liver metastases are present)\n * ALT ≤ 100 IU/L (≤ 200 IU/L if liver metastases are present)\n * Serum creatinine ≤ 1.5 mg/dL\n * PT-INR \\< 1.5 (\\< 3.0 for patients treated with oral warfarin)\n * Satisfies at least one of these conditions\n\n 1. Urine protein (dip stick method) ≤ 1+\n 2. UPC (urine protein creatinine) ratio ≤ 1.0\n 3. Urinary protein ≤ 1000 mg/ 24hours\n9. ECOG performance status (PS) of 0 or 1\n10. Life expectancy of ≥ 3 months (90 days) after enrollment\n\nExclusion Criteria:\n\n1. Radiotherapy received within 4 weeks (28 days) prior to enrollment. Treatments aimed at relieving pain for bone metastases are excluded.\n2. Known brain metastasis or strongly suspected of brain metastasis\n3. Synchronous cancers or metachronous cancers with a disease-free period of ≤ 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.).\n4. Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)\n5. Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy\n6. Nonhealing surgical wound (excluding implanted venous reservoirs)\n7. Active hemorrhage requiring blood transfusion\n8. Disease requiring systemic steroids for treatment (excluding topical steroids)\n9. The patient who has placed colonic stent\n10. Intestinal resection within 4 weeks prior to enrollment or colostomy within 2 weeks prior to enrollmentt\n11. History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)\n12. Patients with unstable angina, myocardial infarction, cerebral hemorrhage, arterial thromboembolism such as cerebral infarction, or have history of these desease less than 24 weeks (168 days) before registration (except for lacunar infarction asymptomatic)\n13. Serious drug hypersensitivity\n14. Local or systemic active infection requiring treatment, or fever indicating infection\n15. NYHA class II or higher heart failure or serious heart disease\n16. Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhoea (incapacitating symptoms despite adequate treatment)\n17. Poorly controlled hypertension\n18. Poorly controlled diabetes mellitus\n19. Active hepatitis B\n20. Known HIV infection\n21. Peripheral neuropathy of ≥ Grade 2 by CTCAE (Japanese edition JCOG version 4.03)\n22. Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study (e.g. Patients who might agree to participate under compulsion).'}, 'identificationModule': {'nctId': 'NCT02394795', 'acronym': 'PARADIGM', 'briefTitle': 'Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase III, Randomized, Controlled Study of mFOLFOX6 + Bevacizumab Combination Therapy Versus mFOLFOX6 + Panitumumab Combination Therapy in Chemotherapy-naive Patients With KRAS/NRAS Wild-type, Incurable/Unresectable, Advanced/Recurrent Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Panitumumab-3001'}, 'secondaryIdInfos': [{'id': 'U1111-1164-9167', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-142731', 'type': 'REGISTRY', 'domain': 'JapicCTI'}, {'id': 'jRCTs031180246', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials'}, {'id': 'UMIN000016776', 'type': 'REGISTRY', 'domain': 'UMIN Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group P; mFOLFOX6 + panitumumab combination therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.', 'interventionNames': ['Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B; mFOLFOX6 + bevacizumab combination therapy', 'description': 'OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.', 'interventionNames': ['Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab']}], 'interventions': [{'name': 'oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab', 'type': 'DRUG', 'description': 'oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion', 'armGroupLabels': ['Group P; mFOLFOX6 + panitumumab combination therapy']}, {'name': 'oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab', 'type': 'DRUG', 'description': 'oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion', 'armGroupLabels': ['Group B; mFOLFOX6 + bevacizumab combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ichinomiya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.3, 'lon': 136.8}}, {'city': 'Komaki', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.28333, 'lon': 136.91667}}, {'city': 'Kōnan', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.33165, 'lon': 136.87042}}, {'city': 'Nagakute', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.17325, 'lon': 137.05667}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Okazaki', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.95, 'lon': 137.16667}}, {'city': 'Toyoake', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'city': 'Toyohashi', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'city': 'Toyokawa', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.81667, 'lon': 137.4}}, {'city': 'Toyota', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.08333, 'lon': 137.15}}, {'city': 'Yatomi', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.1053, 'lon': 136.73378}}, {'city': 'Daisen', 'state': 'Akita', 'country': 'Japan', 'geoPoint': {'lat': 39.44116, 'lon': 140.48961}}, {'city': 'Hirosaki', 'state': 'Aomori', 'country': 'Japan', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'city': 'Misawa', 'state': 'Aomori', 'country': 'Japan', 'geoPoint': {'lat': 40.68682, 'lon': 141.38969}}, {'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'city': 'Yachiyo', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.73531, 'lon': 140.12445}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Tōon', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.79427, 'lon': 132.89011}}, {'city': 'Tsuruga', 'state': 'Fukui', 'country': 'Japan', 'geoPoint': {'lat': 35.653, 'lon': 136.06331}}, {'city': 'Yoshida', 'state': 'Fukui', 'country': 'Japan'}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Koga', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.86429, 'lon': 130.68709}}, {'city': 'Koga', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.73333, 'lon': 130.46667}}, {'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Omuta', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.03333, 'lon': 130.45}}, {'city': 'Aizu-Wakamatsu', 'state': 'Fukushima', 'country': 'Japan', 'geoPoint': {'lat': 37.49142, 'lon': 139.94546}}, {'city': 'Iwaki', 'state': 'Fukushima', 'country': 'Japan', 'geoPoint': {'lat': 37.05, 'lon': 140.88333}}, {'city': 'Kōriyama', 'state': 'Fukushima', 'country': 'Japan', 'geoPoint': {'lat': 37.4, 'lon': 140.38333}}, {'city': 'Shirakawa', 'state': 'Fukushima', 'country': 'Japan', 'geoPoint': {'lat': 37.11954, 'lon': 140.26211}}, {'city': 'Hashima', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.329, 'lon': 136.68051}}, {'city': 'Kakamigahara', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.41667, 'lon': 136.86667}}, {'city': 'Minokamo', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.48199, 'lon': 137.02166}}, {'city': 'Okazai', 'state': 'Gifu', 'country': 'Japan'}, {'city': 'Ōgaki', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.35, 'lon': 136.61667}}, {'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Ōta', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.3, 'lon': 139.36667}}, {'city': 'Fukuyama', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'city': 'Hakodate', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'city': 'Kitami', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.80306, 'lon': 143.89083}}, {'city': 'Kushiro', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 42.975, 'lon': 144.37472}}, {'city': 'Obihiro', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 42.91722, 'lon': 143.20444}}, {'city': 'Otaru', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.18944, 'lon': 141.00222}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'city': 'Amagasaki', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Himeji', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Nishinomiya', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'city': 'Hitachi', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 140.65}}, {'city': 'Kasama', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.38333, 'lon': 140.26667}}, {'city': 'Ryūgasaki', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 35.9, 'lon': 140.18333}}, {'city': 'Tsuchiura', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}, {'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'city': 'Hakusan', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.48204, 'lon': 136.58684}}, {'city': 'Kaga', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.3, 'lon': 136.33333}}, {'city': 'Kahoku', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.75758, 'lon': 136.71162}}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Nanao', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 37.04816, 'lon': 136.96795}}, {'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'city': 'Kida', 'state': 'Kagawa-ken', 'country': 'Japan'}, {'city': 'Marugame', 'state': 'Kagawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.28333, 'lon': 133.78333}}, {'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Fujisawa', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'city': 'Hiratsuka', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.32785, 'lon': 139.33735}}, {'city': 'Isehara', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.39932, 'lon': 139.31019}}, {'city': 'Kamakura', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'city': 'Kanazawachō', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.34368, 'lon': 139.6279}}, {'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokosuka', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'city': 'Nankoku', 'state': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.56943, 'lon': 133.64937}}, {'city': 'Matsuzaka', 'state': 'Mie-ken', 'country': 'Japan'}, {'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'city': 'Yokkaichi', 'state': 'Mie-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.96667, 'lon': 136.61667}}, {'city': 'Ishinomaki', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.41667, 'lon': 141.3}}, {'city': 'Murata', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.11858, 'lon': 140.72434}}, {'city': 'Natori-shi', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.16667, 'lon': 140.88333}}, {'city': 'Ōsaki', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.58866, 'lon': 140.973}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Matsumoto', 'state': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Saku', 'state': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.21667, 'lon': 138.48333}}, {'city': 'Ōmura', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.92139, 'lon': 129.95389}}, {'city': 'Sasebo', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 33.16834, 'lon': 129.72502}}, {'city': 'Ikoma', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 34.68333, 'lon': 135.7}}, {'city': 'Tenri', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 135.83333}}, {'city': 'Yamatotakada', 'state': 'Nara', 'country': 'Japan'}, {'city': 'Yufu', 'state': 'Oita Prefecture', 'country': 'Japan', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Naha', 'state': 'Okinawa', 'country': 'Japan', 'geoPoint': {'lat': 26.213, 'lon': 127.67851}}, {'city': 'Tomigusuku', 'state': 'Okinawa', 'country': 'Japan', 'geoPoint': {'lat': 26.18583, 'lon': 127.68192}}, {'city': 'Urasoe', 'state': 'Okinawa', 'country': 'Japan', 'geoPoint': {'lat': 26.25902, 'lon': 127.73012}}, {'city': 'Hirakata', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'city': 'Kawachi-Nagano', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.44108, 'lon': 135.58283}}, {'city': 'Moriguchi', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.73333, 'lon': 135.56667}}, {'city': 'Neyagawa', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76615, 'lon': 135.62759}}, {'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Kawagoe', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90861, 'lon': 139.48528}}, {'city': 'Kitaadachi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Koshigaya', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'city': 'Moriyama', 'state': 'Shiga', 'country': 'Japan', 'geoPoint': {'lat': 35.06667, 'lon': 135.98333}}, {'city': 'Ōtsu', 'state': 'Shiga', 'country': 'Japan', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'city': 'Izumi', 'state': 'Shimane', 'country': 'Japan'}, {'city': 'Izumo', 'state': 'Shimane', 'country': 'Japan', 'geoPoint': {'lat': 35.36667, 'lon': 132.76667}}, {'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Izunokuni', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 35.03907, 'lon': 138.95143}}, {'city': 'Sunto', 'state': 'Shizuoka', 'country': 'Japan'}, {'city': 'Shimotsuga', 'state': 'Tochigi', 'country': 'Japan'}, {'city': 'Shimotsuke', 'state': 'Tochigi', 'country': 'Japan', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'city': 'Utsunomiya', 'state': 'Tochigi', 'country': 'Japan', 'geoPoint': {'lat': 36.56667, 'lon': 139.88333}}, {'city': 'Komatsushimachō', 'state': 'Tokushima', 'country': 'Japan', 'geoPoint': {'lat': 34.0, 'lon': 134.58333}}, {'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Chiyoda-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Itabashi-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Koto-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Machida', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.54028, 'lon': 139.45083}}, {'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Musashino', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.70611, 'lon': 139.55944}}, {'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Yonago', 'state': 'Tottori', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 133.33333}}, {'city': 'Kurobe-shi', 'state': 'Toyama', 'country': 'Japan', 'geoPoint': {'lat': 36.90123, 'lon': 137.44955}}, {'city': 'Takaoka', 'state': 'Toyama', 'country': 'Japan', 'geoPoint': {'lat': 36.75, 'lon': 137.01667}}, {'city': 'Sakata', 'state': 'Yamagata', 'country': 'Japan', 'geoPoint': {'lat': 38.91667, 'lon': 139.855}}, {'city': 'Tsuruoka', 'state': 'Yamagata', 'country': 'Japan', 'geoPoint': {'lat': 38.72167, 'lon': 139.82167}}, {'city': 'Iwakuni', 'state': 'Yamaguchi', 'country': 'Japan', 'geoPoint': {'lat': 34.16297, 'lon': 132.22}}, {'city': 'Ube', 'state': 'Yamaguchi', 'country': 'Japan', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}, {'city': 'Kofu', 'state': 'Yamanashi', 'country': 'Japan', 'geoPoint': {'lat': 35.66667, 'lon': 138.56667}}, {'city': 'Akita', 'country': 'Japan', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Aomori', 'country': 'Japan', 'geoPoint': {'lat': 40.81667, 'lon': 140.73333}}, {'city': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukui', 'country': 'Japan', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Miyazaki', 'country': 'Japan', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Okayama', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okinawa', 'country': 'Japan', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saga', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokushima', 'country': 'Japan', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'city': 'Toyama', 'country': 'Japan', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Yamagata', 'country': 'Japan', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}