Viewing Study NCT00143403

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Ignite Creation Date: 2025-12-24 @ 7:24 PM
Ignite Modification Date: 2025-12-25 @ 5:04 PM
Study NCT ID: NCT00143403
Status: COMPLETED
Last Update Posted: 2010-09-28
First Post: 2005-09-01
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
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'}, {'id': 'D008113', 'term': 'Liver 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'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '5-FU/FA', 'description': 'simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)', 'otherNumAtRisk': 152, 'otherNumAffected': 146, 'seriousNumAtRisk': 152, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Irinotecan + 5-FU/FA', 'description': 'irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)', 'otherNumAtRisk': 154, 'otherNumAffected': 150, 'seriousNumAtRisk': 154, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Abdominal pain, NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 69}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Anemia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Appetite decreased NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Cholinergic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Diarrhea, NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 98}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Dyspnoea NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Leukopenia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Mucosal inflammation NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 116}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 62}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Pigmentation disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Rhinitis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Vomiting, NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}], 'seriousEvents': [{'term': 'Abdominal pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Anaemia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Axillary vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Cardiac disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Catheter related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Cholecystitis acute NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Diarrhoea NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Gait abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Hepatic disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Injection site thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Intestinal obstruction NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(v5.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal 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