Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-01-06 @ 3:32 AM
Study NCT ID:
NCT02098395
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2014-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk maintains the right to be informed of plans by any investigator to publish and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to Novo Nordisk before submission for comments. Comments will be given within four weeks from receipt of the planned communication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26).', 'description': 'Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'Liraglutide 0.6 mg', 'description': 'Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.', 'otherNumAtRisk': 211, 'otherNumAffected': 137, 'seriousNumAtRisk': 211, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.', 'otherNumAtRisk': 209, 'otherNumAffected': 164, 'seriousNumAtRisk': 209, 'seriousNumAffected': 21}, {'id': 'EG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.', 'otherNumAtRisk': 206, 'otherNumAffected': 162, 'seriousNumAtRisk': 206, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'Liraglutide Placebo', 'description': 'Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.\n\n1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.\n2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.\n3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.', 'otherNumAtRisk': 206, 'otherNumAffected': 125, 'seriousNumAtRisk': 206, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 30, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 43, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 35, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 81, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 122, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 170, 'numAffected': 102}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 40, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 40, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 65, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 59, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 52, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 67, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 56, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 42, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 55, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 33, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 43, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 40, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intervertebral disc injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Traumatic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'VIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Wrist surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Haemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 0.6 mg', 'description': 'Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'OG003', 'title': 'Liraglutide Placebo', 'description': 'Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.\n\n1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.\n2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.\n3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.744', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.731', 'groupId': 'OG001'}, {'value': '-0.32', 'spread': '0.73', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.674', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '-0.2', 'groupDescription': 'Superiority of liraglutide 1.8 mg versus placebo was planned to be concluded if and only if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c was less than zero.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '= 0.0021', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.08', 'groupDescription': 'Superiority of liraglutide 1.2 mg was planned to be evaluated only if superiority for liraglutide 1.8 mg was concluded.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '= 0.0011', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '-0.1', 'groupDescription': 'Superiority of liraglutide 0.6 mg versus placebo was planned to be evaluated only if superiority of liraglutide 1.2 mg was concluded.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 26', 'description': 'Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.', 'unitOfMeasure': 'Percent (%) glycosylated haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of the 831 subjects in FAS, 22 subjects in lira 0.6 mg arm, 33 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 16 in placebo arm did not contribute to this analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 0.6 mg', 'description': 'Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'OG003', 'title': 'Liraglutide Placebo', 'description': 'Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.\n\n1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.\n2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.\n3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.37', 'spread': '3.015', 'groupId': 'OG000'}, {'value': '-4.03', 'spread': '3.677', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '3.787', 'groupId': 'OG002'}, {'value': '-0.26', 'spread': '2.782', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 26', 'description': 'Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 831 subjects in FAS, 27 subjects in lira 0.6 mg arm, 38 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 26 in placebo arm did not contribute to the analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 0.6 mg', 'description': 'Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'OG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'OG003', 'title': 'Liraglutide Placebo', 'description': 'Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.\n\n1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.\n2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.\n3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1437', 'groupId': 'OG000'}, {'value': '1943', 'groupId': 'OG001'}, {'value': '1490', 'groupId': 'OG002'}, {'value': '1567', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-26', 'description': 'Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of \\<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo (SAS = 832 subjects). Symptomatic hypoglycaemic episodes were reported by 166 subjects in liraglutide 0.6 mg arm, 175 subjects in liraglutide 1.2 mg, 160 subjects in liraglutide 1.8 mg arm and 162 subjects in liraglutide placebo arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liraglutide 0.6 mg', 'description': 'Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'FG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'FG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'FG003', 'title': 'Liraglutide Placebo', 'description': 'Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.\n\n1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.\n2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.\n3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '207'}, {'groupId': 'FG003', 'numSubjects': '207'}]}, {'type': 'Exposed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '206'}, {'groupId': 'FG003', 'numSubjects': '206'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '177'}, {'groupId': 'FG002', 'numSubjects': '165'}, {'groupId': 'FG003', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were randomised at 113 sites in 13 countries: Austria 2 sites, Belgium 9 sites, Bulgaria 5 sites, Canada 9 sites, Denmark 4 sites, Finland 6 sites, France 9 sites, Italy 7 sites, Netherlands 5 sites, South Africa 2 sites, Spain 5 sites, Sweden 5 sites, United States 45 sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}, {'value': '831', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Liraglutide 0.6 mg', 'description': 'Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'BG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'BG002', 'title': 'Liraglutide 1.8 mg', 'description': 'Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.'}, {'id': 'BG003', 'title': 'Liraglutide Placebo', 'description': 'Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.\n\n1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.\n2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.\n3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '12.88', 'groupId': 'BG000'}, {'value': '42.8', 'spread': '13.31', 'groupId': 'BG001'}, {'value': '43.2', 'spread': '12.9', 'groupId': 'BG002'}, {'value': '42.7', 'spread': '12.97', 'groupId': 'BG003'}, {'value': '43.2', 'spread': '13.00', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}, {'value': '449', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '382', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated Haemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.09', 'spread': '0.743', 'groupId': 'BG000'}, {'value': '8.07', 'spread': '0.731', 'groupId': 'BG001'}, {'value': '8.04', 'spread': '0.736', 'groupId': 'BG002'}, {'value': '8.12', 'spread': '0.723', 'groupId': 'BG003'}, {'value': '8.08', 'spread': '0.732', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent (%) glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '83.10', 'spread': '16.137', 'groupId': 'BG000'}, {'value': '84.69', 'spread': '18.155', 'groupId': 'BG001'}, {'value': '83.64', 'spread': '17.620', 'groupId': 'BG002'}, {'value': '84.20', 'spread': '16.539', 'groupId': 'BG003'}, {'value': '83.91', 'spread': '17.109', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline (BL) characteristics were presented for full analysis set (FAS = 831 subjects). Out of 835 randomised subjects, 4 were excluded from FAS:1 subject each in the lira 1.8 mg, 0.6 mg and placebo arm were not exposed to trial treatment and 1 subject in the lira 1.8 mg arm had no post-BL measurements.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 835}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2014-03-25', 'resultsFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-26', 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Haemoglobin (HbA1c)', 'timeFrame': 'Week 0, Week 26', 'description': 'Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Week 0, Week 26', 'description': 'Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.'}, {'measure': 'Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-26', 'description': 'Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of \\<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '27493132', 'type': 'RESULT', 'citation': 'Ahren B, Hirsch IB, Pieber TR, Mathieu C, Gomez-Peralta F, Hansen TK, Philotheou A, Birch S, Christiansen E, Jensen TJ, Buse JB; ADJUNCT TWO Investigators. Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial. Diabetes Care. 2016 Oct;39(10):1693-701. doi: 10.2337/dc16-0690. Epub 2016 Aug 4.'}, {'pmid': '27493232', 'type': 'RESULT', 'citation': 'Hoogenhout M, Malcolm-Smith S. Theory of mind predicts severity level in autism. Autism. 2017 Feb;21(2):242-252. doi: 10.1177/1362361316636758. Epub 2016 Aug 19.'}, {'pmid': '39717993', 'type': 'DERIVED', 'citation': 'Shah VN, Agesen RM, Bardtrum L, Christiansen E, Snaith J, Greenfield JR. Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies. J Diabetes Sci Technol. 2025 Mar;19(2):321-331. doi: 10.1177/19322968241305647. Epub 2024 Dec 24.'}, {'pmid': '34463425', 'type': 'DERIVED', 'citation': 'Dejgaard TF, von Scholten BJ, Christiansen E, Kreiner FF, Bardtrum L, von Herrath M, Mathieu C, Madsbad S; ADJUNCT ONE and ADJUNCT TWO Investigators. Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials. Diabetes Obes Metab. 2021 Dec;23(12):2752-2762. doi: 10.1111/dom.14532. Epub 2021 Sep 28.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\n* Male or female, aged equal to or greater than 18 years at the time of signing informed consent\n* Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening)\n* Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)\n* Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator\n* HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC))\n\nExclusion Criteria:\n\n* Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPPIV) inhibitors\n* Use of any medication, which in the investigator's opinion could interfere with the glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect the subject's safety. Premix insulin is not allowed\n* Known proliferative retinopathy or maculopathy requiring acute treatment\n* Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator\n* Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5 minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg for diastolic (repeated measurement at Visit 2 (prior to performing the trial related activities) is allowed to exclude white-coat hypertension)\n* History of acute or chronic pancreatitis\n* Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L"}, 'identificationModule': {'nctId': 'NCT02098395', 'acronym': 'ADJUNCT TWO™', 'briefTitle': 'The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial', 'orgStudyIdInfo': {'id': 'NN9211-4083'}, 'secondaryIdInfos': [{'id': '2012-005778-74', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1138-0619', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'NL47705.060.14', 'type': 'REGISTRY', 'domain': 'CCMO'}, {'id': 'REec-2014-0884', 'type': 'REGISTRY', 'domain': 'Spanish registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide 1.8 mg + insulin', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Liraglutide 1.2 mg + insulin', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Liraglutide 0.6 mg + insulin', 'interventionNames': ['Drug: liraglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Liraglutide placebo 0.3 ml + insulin', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Liraglutide placebo 0.2 ml + insulin', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Liraglutide placebo 0.1 ml + insulin', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.', 'armGroupLabels': ['Liraglutide 1.8 mg + insulin']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': 'Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.', 'armGroupLabels': ['Liraglutide 1.2 mg + insulin']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': 'Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.', 'armGroupLabels': ['Liraglutide 0.6 mg + insulin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.', 'armGroupLabels': ['Liraglutide placebo 0.3 ml + insulin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.', 'armGroupLabels': ['Liraglutide placebo 0.2 ml + insulin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.', 'armGroupLabels': ['Liraglutide placebo 0.1 ml + insulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United 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