Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT01182493
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2010-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reznik-y@chu-caen.fr', 'phone': '+33231064585', 'title': 'Prof. Yves Reznik', 'organization': 'CHU Caen'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events reported during the study period (6 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 108, 'seriousNumAtRisk': 168, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 99, 'seriousNumAtRisk': 163, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SWOLLEN LYMPH NODES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ATRIAL FIBRILLATION REOCCURENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CARDIAC INSUFFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CONGESTIVE HEART FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'HEART BEATING PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ISCHEMIC CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'MIOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'MITRAL INSUFFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SINUSTACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BLOCKED RIGHT EAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'HEARING LOSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'PERICHONDRITIS OF HUMEROSCAPULAR JOINT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'MULTINODULAR GOITER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BEGINNING MACULOPATHY OF THE LEFT EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BILATERAL GLAUCOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'EARLY CATARACTS-BOTH EYES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'IRRITATION LEFT EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LEFT EYE MACULAR EDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'MINIMAL DIABETIC RETINOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'PROLIFERATIVE RETINOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'WORSENED GLAUCOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'WORSENING OF DEGENERATIVE MACULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ABDOMINAL BLOATING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BLACK STOOL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'COLON POLYPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DIARRHEA (DUE TO METFORMIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DIGESTIVE DISORDERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ENTEROCOLLITIS ACUTA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'GASTRO-INTESTINAL SIDE EFFECTS OF METFORMIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'GASTROESOPHAGEAL REFLUX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'GASTROESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'GI REFLUX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INDIGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INTERMITTENT DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INTERMITTENT NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LESIONS ON TONGUE, LIP, AND THROAT.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'MULTIPLE SMALL STOMACH ULCERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'RECTAL BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'STOMACH CRAMPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'TEETH PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'TOOTH PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'VOMITING EPISODE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'VOMITTING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ABDOMINAL BRUISING FROM SENSOR INSERTION SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ANASARCA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ATYPICAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BLEEDING FOLLOWING SENSOR INSERTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BLEEDING FROM INFUSION SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BLEEDING FROM INFUSION SITE UPON REMOVAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'EDEMA - BILATERAL LEGS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'EDEMA IN BOTH LEGS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'FEET SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'FEVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'FLU LIKE SYMPTOMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INFLAMMATION LEFT GROIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INFLAMMATORY NODULE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INFUSION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 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'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ABDOMINAL WALL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ABSCESS - NECK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ABSCESS RIGHT BUTTOCKS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 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ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CELLULITIS - RIGHT FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CELLULITIS ON LEFT ABDOMEN', 'stats': [{'groupId': 'EG000', 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1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DENTAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DIVERTICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'EAR INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ERYSIPELAS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'FLU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'FLU-LIKE SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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{'term': 'GASTRO ENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'H. PYLORI INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'HERPES SIMPLEX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INFECTED TOE ON LEFT FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INFECTION IN LEFT HIP', 'stats': [{'groupId': 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LOCAL INFECTION AROUND PUMP CATETER INSERTION SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LOCAL SKIN INFECTION AT NEEDLE SITE INJECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'MIDDLE EAR INFECTION (OTITIS MEDIA) LEFT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ONYCHOMYCOSIS RIGHT BIG TOE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ONYCHOMYCOSIS.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'OTITIS MEDIA LATERALIS DEXTRI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'PENILE INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'PHARYNGITIS.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'PROBABLE VIRAL GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'RECURRENT SKIN INFECTIONS AFTER REMOVAL OF INFUSION SET', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'RECURRENT SKIN INFECTIONS(INFUSION SITE)EXACERBATION OF AE-4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'RESPIRATORY INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SCROTAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SHINGLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SINUS COLD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SINUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SKIN ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SUBCUTANOUSE ABCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SUPERFICIAL SKIN INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'TONSILITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'TONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'TOOTH ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'TOOTH DECAY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'TOOTH INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'UPPER RESPIRATORY INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 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'EG000', 'numAtRisk': 168, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'VAGINAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'WORSENING SKIN ABSCESS, UNDERARM, BILATERALLY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'YEAST INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ANKLE SPRAIN-RIGHT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ANTERIOR WEDGE COMPRESION FRACTURE OF T12 VERTEBRA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BRUISED LEFT KNEE', 'stats': [{'groupId': 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METATHARSAL BONE RIGHT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'FRACTURED RIGHT MALLEOLUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'HEAD TRAUMA RIGHT TEMPORAL REGION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'HEAT STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INJURY RIGHT LOWER LEG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LEFT 2ND DIGIT INDEX FINGER PROXIMAL PHALANX SKIN REMOVED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LEFT MENISCUS TEAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LEFT THUMB DISLOCATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'POISON IVY (SKIN REACTION)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and 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{'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INCREASED LIVER ENZYMES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INCREASED PRESSURE BEHIND THE RIGHT EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DIABETIC FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 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nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'HYPOMAGNESEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'RECURRING HYPERGLICEMIA (481 MG/DL)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'RIGHT FOOT POSSIBLE GOUT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'SEVERE HYPOGLYCEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'TYPE 1 FHH (FAMILIAL HYPOCALCIURIC HYPERCALCEMIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ADHESIVE CAPSULITIS (FROZEN SHOULDER) LEFT ARM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BAKERｴS CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BILATERAL LEG PAIN BELOW KNEES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 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'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'COXITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DECREASED RANGE OF MOTION RIGHT ARM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DETERIORATION OF RIGHT SHOULDER PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LOW BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LOWER BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LUMBAGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'MUSCLE CRAMPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'MUSCLE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'RIGHT FLANK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'RIGHT KNEE ARTHROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'RIGHT KNEE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 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{'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'TRIGGER FINGER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'VASOVAGAL EPISODE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'WORSENING OF JOINTS PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'WORSENING OF PAIN LEFT LEG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'WORSENING RIGHT SHOULDER PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'BASAL CELL CARCINOMA - RIGHT EAR', 'stats': 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'PLANTARS WART TO LEFT HEEL.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'VERRUCAE VULGARIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CARPAL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CARPEL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CEPHALALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'CERVICAL RADICULOPATHY ON C8', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ELECTIVE SURGERY FOR CARPAL TUNNEL SYNDROME ON LEFT HEND', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'EXACERBATION OF CARPEL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INTERMITTENT NUMBNESS BOTTOM OF RIGHT FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'LOWER LIMBS NEUROPATHIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'EXACERBATION OF PRE EXISTING CONDITION-DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'EXACERBATION OF SYMPTOMS OF DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'STRESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 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{'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'hyperglycemia with ketosis without acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatic Encephalophthy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Atypical Ductal Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Chest Pain (non cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Between Group Difference in HbA1c When Comparing CSII to MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.'}, {'id': 'OG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months', 'description': 'To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period. Change in A1c = A1c at 6 month - A1c at baseline', 'unitOfMeasure': 'Change in % HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.'}, {'id': 'OG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hypo- (≤70mg/dL), among subjects with available AUC results. Change in hypo AUC = hypo AUC at 6 month - hypo AUC at baseline', 'unitOfMeasure': 'mg/dL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety - Severe Hypoglycemia Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.'}, {'id': 'OG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Severe hypoglycemia incidence during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.'}, {'id': 'OG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-11', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '17.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hyper- (≥180mg/dL), among subjects with available AUC results. Change in hyper AUC = hyper AUC at 6 month - hyper AUC at baseline', 'unitOfMeasure': 'mg/dL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.'}, {'id': 'OG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}], 'classes': [{'categories': [{'measurements': [{'value': '4.75', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Subjects were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs). Treatment satisfaction is measured by means of the DTSQs, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 0 to 6. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month compared to baseline represents a better outcome. Change in treatment satisfaction = score at 6 month - score at baseline, among subjects with available satisfaction scores', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.'}, {'id': 'OG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}], 'classes': [{'categories': [{'measurements': [{'value': '1.52', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '3.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in body weight from randomization to the end of study. Change in body weight = weight at 6 month - weight at baseline, among subjects with available body weight', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety - Diabetic Ketoacidosis Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.'}, {'id': 'OG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Diabetic Ketoacidosis incidence during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.'}, {'id': 'FG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': '36 hospitals, tertiary care centres, and referal centres participated: eight in Canada, 23 in Europe and Israel, two in South Africa, and three in the USA. The study started in December 2010, and the fi nal data collection date for the primary outcome measure was in February 2014'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump\n\nInsulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient'}, {'id': 'BG001', 'title': 'Insulin Treatment With MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '0.75', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '0.76', 'groupId': 'BG001'}, {'value': '9.0', 'spread': '0.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2010-08-11', 'resultsFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2010-08-13', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-17', 'studyFirstPostDateStruct': {'date': '2010-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Between Group Difference in HbA1c When Comparing CSII to MDI', 'timeFrame': 'baseline and 6 months', 'description': 'To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period. Change in A1c = A1c at 6 month - A1c at baseline'}], 'secondaryOutcomes': [{'measure': 'Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)', 'timeFrame': '6 months', 'description': 'Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hypo- (≤70mg/dL), among subjects with available AUC results. Change in hypo AUC = hypo AUC at 6 month - hypo AUC at baseline'}, {'measure': 'Safety - Severe Hypoglycemia Incidence', 'timeFrame': '6 months', 'description': 'Severe hypoglycemia incidence during the study'}, {'measure': 'Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)', 'timeFrame': '6 months', 'description': 'Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hyper- (≥180mg/dL), among subjects with available AUC results. Change in hyper AUC = hyper AUC at 6 month - hyper AUC at baseline'}, {'measure': 'Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)', 'timeFrame': '6 months', 'description': 'Subjects were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs). Treatment satisfaction is measured by means of the DTSQs, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 0 to 6. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month compared to baseline represents a better outcome. Change in treatment satisfaction = score at 6 month - score at baseline, among subjects with available satisfaction scores'}, {'measure': 'Change in Body Weight', 'timeFrame': '6 months', 'description': 'Change in body weight from randomization to the end of study. Change in body weight = weight at 6 month - weight at baseline, among subjects with available body weight'}, {'measure': 'Safety - Diabetic Ketoacidosis Incidence', 'timeFrame': '6 Months', 'description': 'Diabetic Ketoacidosis incidence during the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'MDI', 'pump therapy'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '29215299', 'type': 'DERIVED', 'citation': 'Chlup R, Runzis S, Castaneda J, Lee SW, Nguyen X, Cohen O. Complex Assessment of Metabolic Effectiveness of Insulin Pump Therapy in Patients with Type 2 Diabetes Beyond HbA1c Reduction. Diabetes Technol Ther. 2018 Feb;20(2):153-159. doi: 10.1089/dia.2017.0283. Epub 2017 Dec 7.'}, {'pmid': '28374511', 'type': 'DERIVED', 'citation': 'Metzger M, Castaneda J, Reznik Y, Giorgino F, Conget I, Aronson R, de Portu S, Runzis S, Lee SW, Cohen O. Factors associated with improved glycemic control following continuous subcutaneous insulin infusion therapy in patients with type 2 diabetes uncontrolled with bolus-basal insulin regimens: An analysis from the OpT2mise randomized trial. Diabetes Obes Metab. 2017 Oct;19(10):1490-1494. doi: 10.1111/dom.12960. Epub 2017 Jul 25.'}, {'pmid': '24998009', 'type': 'DERIVED', 'citation': 'Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.'}], 'seeAlsoLinks': [{'url': 'http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61037-0/abstract', 'label': 'Publication of primary endpoints in the Lancet'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the comparative effectiveness of insulin pump therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are sub optimally controlled with multiple daily injections (MDI).', 'detailedDescription': 'The type of study is interventional post-market release. All the devices under investigation have CE mark, and are used within intended use.\n\nThis study has been designed to be prospective randomized controlled with a single-arm cross-over in the continuation phase.\n\nFour hundred type 2 Multiple Daily Injections (MDI) treated patients will undergo a screening (run-in) phase of 8 weeks. The aim of the screening phase is to eliminate the study effect that might result in a decrease of HbA1c and to make sure that patients, who are failing current MDI therapy, are selected.\n\nAfter this screening phase, eligible patients will be randomised to receive either Continuous Subcutaneous Insulin Infusion (CSII) treatment or continue MDI treatment. The study phase is a 6-months phase with 2-arms parallel design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria at screening:\n\n1. Diagnosed with type 2 DM, as per Investigator discretion\n2. HbA1c (DCCT-standard) must be ≥ 8.0% and ≤12% as evidenced by central lab value taken at screening\n3. Insulin resistance defined as required daily dose between 0.5-1.8 U/Kg or a maximum of 220 units of insulin per day\n4. Aged 30 to 75 years old (inclusive)\n5. On MDI regimen (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as ≥ 3 injections per day for at least 3 months prior signing the informed consent\n6. Ability to comply with technology, according to Investigator's judgment\n7. Patients must be willing to undergo all study procedures\n8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator\n\nat randomisation:\n\n1. Diagnosed with type 2 DM, as per Investigator discretion\n2. HbA1c (DCCT-standard) must be ≥ 8.0% and ≤12% as evidenced by central lab value\n3. Insulin resistance defined as required daily dose between 0.7-1.8 U/Kg or a maximum of 220 units of insulin per day\n4. On MDI (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as ≥ 3 injections per day\n5. Ability to comply with technology, according to Investigator's judgment\n6. ≥ 2.5 SMBG per day on average, as reported in Carelink clinical during the run-in phase.\n7. Patients must be willing to undergo all study procedures\n8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator\n\nExclusion Criteria :\n\n1. Subject has a history (≥ 2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months\n2. Subject is pregnant as assessed by a pregnancy test with central laboratory, or plans to become pregnant during the course of the study\n3. Participation in another interventional clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.\n4. Subject has proliferative retinopathy or sight threatening maculopathy\n5. Subject has\n\n * an acute coronary syndrome (myocardial infarction or unstable angina) within 12 months OR\n * coronary artery revascularization by bypass surgery or stenting within 3 months OR\n * a transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 3 months OR\n * hospitalization for heart failure within 3 months or current New York Functional Class III or IV OR\n * current 2nd or 3rd degree heart block OR\n * symptomatic ventricular rhythm disturbances OR\n * thromboembolic disease within the last 3 months OR\n * 2nd degree Mobitz type II or 3rd degree heart block\n6. Subject with renal impairment expressed as estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula \\< 30 ml/min as demonstrated by the screening central laboratory value at the time of enrollment\n7. Subject has taken oral or injectable steroids within the last 30 days\n8. Systolic blood pressure on screening visit is \\> 180 mmHg\n9. Diastolic blood pressure on screening visit is \\> 110 mmHg\n10. Any other disease (eg active cancer under treatment) or condition including abnormalities found on the screening tests, that in the opinion of the Investigator, may preclude him/her from participating in the study\n11. Taking any medication prescribed for weight loss\n12. Alcohol or drug abuse, other than nicotine, at the investigator's discretion\n13. Use of a GLP-1 agonist or pramlintide (Symlin)"}, 'identificationModule': {'nctId': 'NCT01182493', 'acronym': 'OpT2mise', 'briefTitle': 'OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Diabetes'}, 'officialTitle': 'OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy', 'orgStudyIdInfo': {'id': 'EUR05 / CEP234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Pump Treatment', 'description': 'Patients will get an insulin pump', 'interventionNames': ['Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)']}, {'type': 'NO_INTERVENTION', 'label': 'Insulin treatment with MDI', 'description': 'patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day'}], 'interventions': [{'name': 'Insulin Pump (Medtronic Minimed Paradigm® VEO)', 'type': 'DEVICE', 'otherNames': ['Medtronic MiniMed Paradigm® VEO system (MMT-554/754'], 'description': 'The pump delivers insulin as specified by the patient', 'armGroupLabels': ['Insulin Pump Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'City hopital Vienna-Hieting', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'T3B 0M3', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Clinical Professor Department of Medicine University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V3L 3W5', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Endocrinologist, 202-301 Columbia Street East', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': 'V6E 1M7', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': '416-1033 Davie St', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Health Science Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'L6H 3P1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Endocrinology Centre', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'K7A 4W8', 'city': 'Smiths Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canadian Centre for Research on Diabetes', 'geoPoint': {'lat': 44.90452, 'lon': -76.02333}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hsopital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University, McGill Nutrition and Food Science Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Côte de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '13274', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU - Ste Marguerite', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54500', 'city': 'Nancy', 'country': 'France', 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '83670', 'city': 'Bad Heilbrunn', 'country': 'Germany', 'facility': 'Fachklinik Bad Heilbrunn', 'geoPoint': {'lat': 47.74671, 'lon': 11.45934}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'Zentrum für Diabetes und Gefäßerkrankungen', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '1076', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '84105', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '93106', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Diabetic Clinic', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '5262', 'city': 'Tel Hashomer - Ramat Gan', 'country': 'Israel', 'facility': 'Chaim Sheba Medical center Endocrinology unit'}, {'zip': '70300', 'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Assaf- Harofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Università degli Studi di Bari - Policlinico Universitario', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '06132', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Universita di Perugia - Ospedale S.M. Della Misericordia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'University La Sapienza - Policlinico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '2906', 'city': 'Capelle aan den IJssel', 'country': 'Netherlands', 'facility': 'IJsselland Ziekenhuis Poli Interne geneeskunde', 'geoPoint': {'lat': 51.92917, 'lon': 4.57778}}, {'zip': '5600', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Maxima Medisch Centrum', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '7900', 'city': 'Hoogeveen', 'country': 'Netherlands', 'facility': 'Bethesda Diabetes Research Center', 'geoPoint': {'lat': 52.7225, 'lon': 6.47639}}, {'zip': '1000', 'city': 'Skopje', 'country': 'North Macedonia', 'facility': 'University Clinic of Endocrinology', 'geoPoint': {'lat': 41.99646, 'lon': 21.43141}}, {'zip': '11 000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinic for Endocrinology, Diabetes and Metabolic Diseases', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '2198', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Centre for Diabetes and Endocrinology', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '6001', 'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Dr.Garcjan Podgorski', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'ICMDM Hospital Clínic i Universitari', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Ohad Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chaim Sheba Medical Center, Tel Hashomer, Israel'}, {'name': 'Ignacio Conget, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICMDM Hospital Clínic i, Barcelona, Spain'}, {'name': 'Yves Reznic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Côte de Nacre, France'}, {'name': 'Ronnie Aronson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FRCPC, FACE LMC Endocrinology Centres, Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Diabetes', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}