Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-01 @ 5:01 PM
Study NCT ID:
NCT01504412
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2012-01-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598618', 'term': 'mirogabalin'}, {'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dsclinicaltrial@daiichisankyo.co.jp', 'phone': '+81 362251111 (M-F 9-5 JST)', 'title': 'Contact for Clinical Trial Information', 'organization': 'Daiichi Sankyo, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the time the Informed Consent Form was signed to 7 days after the last dose of study medication, approximately 18 months.', 'description': 'Adverse events that appeared for the first time during treatment, or that worsened relative to the pre-treatment state, were analyzed. Additionally, 3 participants who had major violations of GCP were excluded from the Safety Analysis Set (1 participant each in the placebo, pregabalin, and in the 20-mg/day group).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 13, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Pregabalin', 'description': 'Pregabalin capsules 300 mg/day administered in 2 doses', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 28, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'DS-5565 10 mg/Day', 'description': 'DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 18, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'DS-5565 20 mg/Day', 'description': 'DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 38, 'seriousNumAtRisk': 93, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'DS-5565 30 mg/Day', 'description': 'DS-5565 30mg/day, administered in 2 doses (15 mg twice daily). Treatment period: 1 week titration and 6 weeks of fixed dose.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 42, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Metastases to lymph node', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin capsules 300 mg/day administered in 2 doses'}, {'id': 'OG002', 'title': 'DS-5565 10 mg/Day', 'description': 'DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily).'}, {'id': 'OG003', 'title': 'DS-5565 20 mg/Day', 'description': 'DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily).'}, {'id': 'OG004', 'title': 'DS-5565 30 mg/Day', 'description': 'DS-5565 30mg/day, administered in 2 doses (15 mg twice daily).'}], 'classes': [{'title': 'Baseline to Week 1', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '-0.69', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '-0.88', 'spread': '1.32', 'groupId': 'OG003'}, {'value': '-0.60', 'spread': '1.01', 'groupId': 'OG004'}]}]}, {'title': 'Baseline to Week 2', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '-1.16', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '-1.21', 'spread': '1.56', 'groupId': 'OG003'}, {'value': '-1.06', 'spread': '1.28', 'groupId': 'OG004'}]}]}, {'title': 'Baseline to Week 3', 'categories': [{'measurements': [{'value': '-1.05', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '-1.50', 'spread': '1.68', 'groupId': 'OG003'}, {'value': '-1.35', 'spread': '1.52', 'groupId': 'OG004'}]}]}, {'title': 'Baseline to Week 4', 'categories': [{'measurements': [{'value': '-1.12', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '-1.50', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '-1.65', 'spread': '1.68', 'groupId': 'OG003'}, {'value': '-1.56', 'spread': '1.53', 'groupId': 'OG004'}]}]}, {'title': 'Baseline to Week 5', 'categories': [{'measurements': [{'value': '-1.28', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '-1.62', 'spread': '1.32', 'groupId': 'OG002'}, {'value': '-1.68', 'spread': '1.80', 'groupId': 'OG003'}, {'value': '-1.47', 'spread': '1.61', 'groupId': 'OG004'}]}]}, {'title': 'Baseline to Week 6', 'categories': [{'measurements': [{'value': '-1.41', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '1.51', 'groupId': 'OG001'}, {'value': '-1.79', 'spread': '1.31', 'groupId': 'OG002'}, {'value': '-1.78', 'spread': '1.68', 'groupId': 'OG003'}, {'value': '-1.68', 'spread': '1.50', 'groupId': 'OG004'}]}]}, {'title': 'Baseline to Week 7', 'categories': [{'measurements': [{'value': '-1.50', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-1.55', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '-1.82', 'spread': '1.36', 'groupId': 'OG002'}, {'value': '-1.91', 'spread': '1.77', 'groupId': 'OG003'}, {'value': '-1.75', 'spread': '1.68', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1995', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '0.15', 'pValueComment': 'Dunnett method was used for adjustment of multiple testing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2886', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '0.20', 'pValueComment': 'Dunnett method was used for adjustment of multiple testing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4704', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.27', 'pValueComment': 'Dunnett method was used for adjustment of multiple testing.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 7 postdose', 'description': "The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \\[no pain\\] to 10 \\[worst possible pain\\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point \\[scale of 0 to 10\\] versus placebo.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean change in ADPS was assessed in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '90', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.'}, {'id': 'OG001', 'title': 'Pregabalin', 'description': 'Pregabalin capsules 300 mg/day administered in 2 doses'}, {'id': 'OG002', 'title': 'DS-5565 10 mg/Day', 'description': 'DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily).'}, {'id': 'OG003', 'title': 'DS-5565 20 mg/Day', 'description': 'DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily).'}, {'id': 'OG004', 'title': 'DS-5565 30 mg/Day', 'description': 'DS-5565 30mg/day, administered in 2 doses (15 mg twice daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.7', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-17.2', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '-21.9', 'spread': '2.01', 'groupId': 'OG002'}, {'value': '-22.1', 'spread': '1.97', 'groupId': 'OG003'}, {'value': '-24.2', 'spread': '2.00', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0691', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.2', 'ciLowerLimit': '-10.8', 'ciUpperLimit': '0.4', 'groupDescription': 'This analysis assessed placebo vs DS-5565 10 mg/day for the visual analog scale.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0577', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.4', 'ciLowerLimit': '-10.9', 'ciUpperLimit': '0.2', 'groupDescription': 'This analysis assessed placebo vs DS-5565 20 mg/day for the visual analog scale.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0093', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.4', 'ciLowerLimit': '-13.0', 'ciUpperLimit': '-1.8', 'groupDescription': 'This analysis assessed placebo vs DS-5565 30 mg/day for the visual analog scale.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at Week 7 postdose', 'description': 'The Short Form-McGill Pain Questionnaire (SF-MPQ) Visual Analog Scale (VAS) is reported. For VAS, participants rated pain intensity on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.\n\nGreater mean changes (improvements) in SF-MPQ indicated better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean change in SF-MPQ VAS was assessed in the Full Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.'}, {'id': 'FG001', 'title': 'Pregabalin', 'description': 'Pregabalin capsules 300 mg/day administered in 2 doses'}, {'id': 'FG002', 'title': 'DS-5565 10 mg/Day', 'description': 'DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily).'}, {'id': 'FG003', 'title': 'DS-5565 20 mg/Day', 'description': 'DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily).'}, {'id': 'FG004', 'title': 'DS-5565 30 mg/Day', 'description': 'DS-5565 30mg/day, administered in 2 doses (15 mg twice daily).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '94'}, {'groupId': 'FG004', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '86'}, {'groupId': 'FG003', 'numSubjects': '75'}, {'groupId': 'FG004', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'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': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants who met all inclusion criteria and none of the exclusion criteria were enrolled and randomized to treatment.', 'preAssignmentDetails': 'Enrolled participants were equally randomized (1:1:1:1:1) to placebo, pregabalin, or one of three different doses of DS-5565 in a double-blind fashion. After randomization, participants received one-half the fixed dose for the first week, and subsequently received the fixed dose for 6 weeks. All participants were followed for an additional week.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '450', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.'}, {'id': 'BG001', 'title': 'Pregabalin', 'description': 'Pregabalin capsules 300 mg/day administered in 2 doses'}, {'id': 'BG002', 'title': 'DS-5565 10 mg/Day', 'description': 'DS-5565 10 mg/day, administered in 2 doses (5 mg twice daily).'}, {'id': 'BG003', 'title': 'DS-5565 20 mg/Day', 'description': 'DS-5565 20 mg/day, administered in 2 doses (10 mg twice daily).'}, {'id': 'BG004', 'title': 'DS-5565 30 mg/Day', 'description': 'DS-5565 30mg/day, administered in 2 doses (15 mg twice daily).'}, {'id': 'BG005', '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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '310', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '140', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '9.79', 'groupId': 'BG000'}, {'value': '60.1', 'spread': '8.74', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '9.77', 'groupId': 'BG002'}, {'value': '60.9', 'spread': '9.32', 'groupId': 'BG003'}, {'value': '59.0', 'spread': '10.06', 'groupId': 'BG004'}, {'value': '59.8', 'spread': '9.55', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '160', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '290', 'groupId': 'BG005'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '450', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '450', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2012-01-03', 'resultsFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2012-01-04', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-16', 'studyFirstPostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy', 'timeFrame': 'Baseline to Week 7 postdose', 'description': "The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \\[no pain\\] to 10 \\[worst possible pain\\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point \\[scale of 0 to 10\\] versus placebo."}], 'secondaryOutcomes': [{'measure': 'Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy', 'timeFrame': 'at Week 7 postdose', 'description': 'The Short Form-McGill Pain Questionnaire (SF-MPQ) Visual Analog Scale (VAS) is reported. For VAS, participants rated pain intensity on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.\n\nGreater mean changes (improvements) in SF-MPQ indicated better outcomes.'}]}, 'conditionsModule': {'keywords': ['Pain', 'Diabetic Peripheral Neuropathy'], 'conditions': ['Pain', 'Diabetic Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '32052264', 'type': 'DERIVED', 'citation': 'Baba M, Kuroha M, Ohwada S, Murayama E, Matsui N. Results of Mirogabalin Treatment for Diabetic Peripheral Neuropathic Pain in Asian Subjects: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study. Pain Ther. 2020 Jun;9(1):261-278. doi: 10.1007/s40122-020-00156-6. Epub 2020 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 or Type 2 diabetes mellitus\n* Painful distal symmetric polyneuropathy\n* Average daily pain score is great than or equal to 4\n\nExclusion Criteria:\n\n* HbA1c greater than 9.0'}, 'identificationModule': {'nctId': 'NCT01504412', 'briefTitle': 'Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'An Asian, Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Pregabalin-controlled, Dose-finding Study of DS-5565 in Patients With Pain Associated With Diabetic Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'DS5565-A-J202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DS-5565 Low Dose', 'description': 'DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.', 'interventionNames': ['Drug: DS-5565']}, {'type': 'EXPERIMENTAL', 'label': 'DS-5565 Middle Dose', 'description': 'DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.', 'interventionNames': ['Drug: DS-5565']}, {'type': 'EXPERIMENTAL', 'label': 'DS-5565 High Dose', 'description': 'DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose.', 'interventionNames': ['Drug: DS-5565']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': 'Pregabalin capsules 300mg/day administered in 2 doses', 'interventionNames': ['Drug: Pregabalin capsules']}], 'interventions': [{'name': 'DS-5565', 'type': 'DRUG', 'description': 'Oral tablets administered twice daily', 'armGroupLabels': ['DS-5565 Low Dose']}, {'name': 'DS-5565', 'type': 'DRUG', 'description': 'Oral tablets administered twice daily', 'armGroupLabels': ['DS-5565 Middle Dose']}, {'name': 'DS-5565', 'type': 'DRUG', 'description': 'Oral tablets administered twice daily', 'armGroupLabels': ['DS-5565 High Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day', 'armGroupLabels': ['Placebo']}, {'name': 'Pregabalin capsules', 'type': 'DRUG', 'description': 'Pregabalin oral capsules 150 mg administered twice a day', 'armGroupLabels': ['Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, '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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}