Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-13 @ 9:55 AM
Study NCT ID:
NCT02318706
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2014-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598618', 'term': 'mirogabalin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo@dsi.com', 'phone': '1-908-992-6400', 'title': 'Contact for Clinical Trial Information', 'organization': 'Daiichi Sankyo, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected after the participant signed the informed consent up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 6 months.', 'description': 'A total of 824 participants were included in the Safety Analysis Set. An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory value or abnormal vital sign), symptom, or disease that developed, regardless of relationship to the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.', 'otherNumAtRisk': 330, 'deathsNumAtRisk': 330, 'otherNumAffected': 101, 'seriousNumAtRisk': 330, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'DS-5565 15mg QD', 'description': 'Participants who received an oral dose of DS-5565 15 mg every day (QD).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week.\n\nDuring the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 60, 'seriousNumAtRisk': 164, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'DS-5565 20 mg (10 mg BID)', 'description': 'Participants who received an oral dose of DS-5565 20 mg (10 mg BID).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week.\n\nDuring the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 62, 'seriousNumAtRisk': 165, 'deathsNumAffected': 2, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'DS-5565 30 mg (15 mg BID)', 'description': 'Participants who received an oral dose of DS-5565 30 mg (15 mg BID).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week.\n\nDuring the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 84, 'seriousNumAtRisk': 165, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'DS-5565 Open-label Extension', 'description': 'Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 141, 'seriousNumAtRisk': 214, 'deathsNumAffected': 1, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 25}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Perinephric abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebal infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Burns third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral arterial occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fractured sacrum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ulnar nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.'}, {'id': 'OG001', 'title': 'DS-5565 15mg QD', 'description': 'Participants who received an oral dose of DS-5565 15 mg every day (QD).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week.\n\nDuring the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.'}, {'id': 'OG002', 'title': 'DS-5565 20 mg (10 mg BID)', 'description': 'Participants who received an oral dose of DS-5565 20 mg (10 mg BID).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week.\n\nDuring the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.'}, {'id': 'OG003', 'title': 'DS-5565 30 mg (15 mg BID)', 'description': 'Participants who received an oral dose of DS-5565 30 mg (15 mg BID).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week.\n\nDuring the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '0.85', 'groupId': 'OG002'}, {'value': '-0.60', 'spread': '1.01', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.72', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '-1.00', 'spread': '1.27', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '-1.33', 'spread': '1.49', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-0.94', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '-1.43', 'spread': '1.63', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '-1.06', 'spread': '1.50', 'groupId': 'OG002'}, {'value': '-1.48', 'spread': '1.68', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-0.92', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '-1.13', 'spread': '1.52', 'groupId': 'OG002'}, {'value': '-1.58', 'spread': '1.73', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-1.03', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '-1.13', 'spread': '1.59', 'groupId': 'OG002'}, {'value': '-1.57', 'spread': '1.72', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.09', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '-1.26', 'spread': '1.59', 'groupId': 'OG002'}, {'value': '-1.53', 'spread': '1.79', 'groupId': 'OG003'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '-1.16', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '-1.27', 'spread': '1.56', 'groupId': 'OG002'}, {'value': '-1.63', 'spread': '1.76', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-1.18', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '-1.33', 'spread': '1.65', 'groupId': 'OG002'}, {'value': '-1.67', 'spread': '1.83', 'groupId': 'OG003'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '-1.36', 'spread': '1.64', 'groupId': 'OG002'}, {'value': '-1.69', 'spread': '1.80', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.28', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '-1.36', 'spread': '1.67', 'groupId': 'OG002'}, {'value': '-1.82', 'spread': '1.84', 'groupId': 'OG003'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '-1.32', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '-1.43', 'spread': '1.72', 'groupId': 'OG002'}, {'value': '-1.85', 'spread': '1.93', 'groupId': 'OG003'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '-1.37', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '1.74', 'groupId': 'OG001'}, {'value': '-1.47', 'spread': '1.69', 'groupId': 'OG002'}, {'value': '-1.88', 'spread': '1.88', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8773', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.30', 'groupDescription': 'Week 14 change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.'}, {'pValue': '0.3494', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.17', 'groupDescription': 'Week 14 change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.'}, {'pValue': '0.0027', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '-0.17', 'groupDescription': 'Week 14 change from baseline', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg])', 'description': 'Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary).\n\nIn this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ADPS was assessed in the Modified-Intent-to-Treat Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DS-5565 Open-label Extension', 'description': 'Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.'}], 'classes': [{'title': 'Week 16', 'categories': [{'measurements': [{'value': '-0.90', 'spread': '9.190', 'groupId': 'OG000'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '-4.00', 'spread': '11.140', 'groupId': 'OG000'}]}]}, {'title': 'Week 22', 'categories': [{'measurements': [{'value': '-7.00', 'spread': '12.690', 'groupId': 'OG000'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '-6.20', 'spread': '11.430', 'groupId': 'OG000'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '-7.20', 'spread': '12.620', 'groupId': 'OG000'}]}]}, {'title': 'Week 34', 'categories': [{'measurements': [{'value': '-7.80', 'spread': '13.260', 'groupId': 'OG000'}]}]}, {'title': 'Week 38', 'categories': [{'measurements': [{'value': '-7.30', 'spread': '15.230', 'groupId': 'OG000'}]}]}, {'title': 'Week 42', 'categories': [{'measurements': [{'value': '-8.00', 'spread': '14.420', 'groupId': 'OG000'}]}]}, {'title': 'Week 46', 'categories': [{'measurements': [{'value': '-8.10', 'spread': '15.780', 'groupId': 'OG000'}]}]}, {'title': 'Week 50', 'categories': [{'measurements': [{'value': '-7.80', 'spread': '15.100', 'groupId': 'OG000'}]}]}, {'title': 'Week 54', 'categories': [{'measurements': [{'value': '-9.20', 'spread': '14.360', 'groupId': 'OG000'}]}]}, {'title': 'Week 58', 'categories': [{'measurements': [{'value': '-8.80', 'spread': '14.940', 'groupId': 'OG000'}]}]}, {'title': 'Week 62', 'categories': [{'measurements': [{'value': '-10.00', 'spread': '15.390', 'groupId': 'OG000'}]}]}, {'title': 'Week 66', 'categories': [{'measurements': [{'value': '-10.80', 'spread': '13.950', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline (Week 14) to Week 66', 'description': "Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome.\n\nIn this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Visual analog scale was assessed in all enrolled participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.'}, {'id': 'FG001', 'title': 'DS-5565 15mg QD', 'description': 'Participants who received an oral dose of DS-5565 15 mg every day (QD).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week.\n\nDuring the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.'}, {'id': 'FG002', 'title': 'DS-5565 20 mg (10 mg BID)', 'description': 'Participants who received an oral dose of DS-5565 20 mg (10 mg BID).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week.\n\nDuring the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.'}, {'id': 'FG003', 'title': 'DS-5565 30 mg (15 mg BID)', 'description': 'Participants who received an oral dose of DS-5565 30 mg (15 mg BID).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week.\n\nDuring the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.'}, {'id': 'FG004', 'title': 'DS-5565 Open-label Extension', 'description': 'Participants who received an oral dose of DS-5565 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage was escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings.'}], 'periods': [{'title': 'Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '334'}, {'groupId': 'FG001', 'numSubjects': '166'}, {'groupId': 'FG002', 'numSubjects': '168'}, {'groupId': 'FG003', 'numSubjects': '166'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '150'}, {'groupId': 'FG003', 'numSubjects': '142'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Open-label Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'A portion of participants who completed the double-blind phase enrolled in the open-label extension.', 'groupId': 'FG004', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '21'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'A total of 854 participants who met all inclusion and no exclusion criteria were enrolled; 834 were randomized to treatment in the double-blind phase. Twenty participants were excluded by the sponsor due to a serious Good Clinical Practice violation (inform consent form-related). A total of 214 participants enrolled in the open-label extension.', 'preAssignmentDetails': 'Participants were randomized to DS-5565 (15, 20, or 30 mg) or placebo in the double-blind (DB) phase and open-label DS-5565 in the long-term (LT) phase. Patients who complete the DB phase may not enroll in the LT phase. DB phase determine significant difference vs placebo (\\~750 target cases). LT phase confirm long-term safety (\\~180 target cases).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}, {'value': '834', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants who received an oral dose of placebo twice daily (BID) for 14 weeks.'}, {'id': 'BG001', 'title': 'DS-5565 15mg QD', 'description': 'Participants who received an oral dose of DS-5565 15 mg QD.\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week.\n\nDuring the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks.'}, {'id': 'BG002', 'title': 'DS-5565 20 mg (10 mg BID)', 'description': 'Participants who received an oral dose of DS-5565 20 mg (10 mg BID).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week.\n\nDuring the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks.'}, {'id': 'BG003', 'title': 'DS-5565 30 mg (15 mg BID)', 'description': 'Participants who received an oral dose of DS-5565 30 mg (15 mg BID).\n\nDuring the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week.\n\nDuring the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks.'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '497', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '337', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '61.9', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '61.8', 'spread': '9.4', 'groupId': 'BG003'}, {'value': '61.4', 'spread': '9.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '229', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}, {'value': '605', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}, {'value': '834', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}, {'value': '834', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-18', 'size': 18077071, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-24T19:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 854}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2014-12-11', 'resultsFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2014-12-11', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-29', 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain', 'timeFrame': 'Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg])', 'description': 'Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary).\n\nIn this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain', 'timeFrame': 'From baseline (Week 14) to Week 66', 'description': "Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome.\n\nIn this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic Peripheral Neuropathic Pain'], 'conditions': ['Diabetic Peripheral Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '34059327', 'type': 'DERIVED', 'citation': 'Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29.'}]}, 'descriptionModule': {'briefSummary': 'Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo', 'detailedDescription': '\\[Double Blind Phase\\] The primary objective is to compare change in the Average Daily Pain Score(ADPS) from baseline to Week 14 in Asian subjects with DPNP receiving DS-5565 versus placebo.\n\n\\[Open Extension Phase\\] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with DPNP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 or type 2 diabetes mellitus at screening\n* Painful distal symmetric polyneuropathy\n* At screening, a pain scale of ≥ 40 mm\n\nExclusion Criteria:\n\n* HbA1c (National Glycohemoglobin Standardization Program) \\> 10.0%'}, 'identificationModule': {'nctId': 'NCT02318706', 'briefTitle': 'DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Diabetic Peripheral Neuropathic Pain Followed by a 52-Week Open-label Extension', 'orgStudyIdInfo': {'id': 'DS5565-A-J303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo group (14 weeks)', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DS-5565 15mg', 'description': 'DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose', 'interventionNames': ['Drug: DS-5565']}, {'type': 'EXPERIMENTAL', 'label': 'DS-5565 20 mg group', 'description': 'DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose', 'interventionNames': ['Drug: DS-5565']}, {'type': 'EXPERIMENTAL', 'label': 'DS-5565 30 mg group', 'description': 'DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose', 'interventionNames': ['Drug: DS-5565']}], 'interventions': [{'name': 'DS-5565', 'type': 'DRUG', 'otherNames': ['mirogabalin'], 'armGroupLabels': ['DS-5565 15mg', 'DS-5565 20 mg group', 'DS-5565 30 mg group']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '876-0851', 'city': 'Ōita', 'country': 'Japan', 'facility': 'Saiki Central Hospital', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}], 'overallOfficials': [{'name': 'Global Clinical Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CMIC Co, Ltd. Japan', 'class': 'INDUSTRY'}, {'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}, {'name': 'Quintiles Malaysia Sdn Bhd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}