Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-29 @ 3:55 PM
Study NCT ID:
NCT02058992
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2014-02-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C495910', 'term': 'ramelteon'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 6 weeks', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Ramelteon', 'description': 'Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.', 'otherNumAtRisk': 3223, 'otherNumAffected': 37, 'seriousNumAtRisk': 3223, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3223, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3223, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 weeks', 'description': "Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set was defined as participants who were enrolled and completed the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Serious Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 weeks', 'description': "Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS was defined as participants who were enrolled and completed the study.'}, {'type': 'SECONDARY', 'title': 'Sleep Status: Sleep Onset Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1429', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '89.8', 'spread': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '47.1', 'spread': '46.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.'}, {'type': 'SECONDARY', 'title': 'Sleep Status: Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.49', 'spread': '2.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '7.31', 'spread': '1.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.'}, {'type': 'SECONDARY', 'title': 'Sleep Status: Number of Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1401', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation.', 'unitOfMeasure': 'number of awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2788', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.'}], 'classes': [{'title': 'Sleep onset', 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000'}]}]}, {'title': 'Sleep time', 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000'}]}]}, {'title': 'Sleep quality', 'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000'}]}]}, {'title': 'Morning awakening', 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000'}]}]}, {'title': 'Morning tiredness', 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime sleepiness', 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000'}]}]}, {'title': 'Daytime physical condition/function', 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'PGI is a participant rated instrument to measure participant\'s change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ramelteon', 'description': 'Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3339'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3223'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}]}, {'type': 'CRF Uncollected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 557 investigative site in Japan from 30 July 2010 to 30 April 2013.', 'preAssignmentDetails': 'Participants with a historical diagnosis of insomnia who were facing difficulty in falling asleep in daily clinical practice were enrolled in single treatment group to receive ramelteon 8 milligram (mg).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3223', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ramelteon', 'description': 'Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '18.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Less than (<) 65 years', 'categories': [{'measurements': [{'value': '1379', 'groupId': 'BG000'}]}]}, {'title': 'Greater than or equal to (>=)65 years to <75 years', 'categories': [{'measurements': [{'value': '733', 'groupId': 'BG000'}]}]}, {'title': '>=75 years', 'categories': [{'measurements': [{'value': '1111', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1935', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1288', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Sleep Disorder (Major Symptoms)', 'classes': [{'title': 'Difficulty falling asleep', 'categories': [{'measurements': [{'value': '1966', 'groupId': 'BG000'}]}]}, {'title': 'Difficulty getting sound sleep', 'categories': [{'measurements': [{'value': '302', 'groupId': 'BG000'}]}]}, {'title': 'Difficulty staying asleep', 'categories': [{'measurements': [{'value': '458', 'groupId': 'BG000'}]}]}, {'title': 'Early morning awakening', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '447', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Sleep disorder was categorized on the basis of symptoms found in participants.', 'unitOfMeasure': 'participants'}, {'title': 'Degree of Sleep Disorder', 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '1354', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1569', 'groupId': 'BG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Degree of sleep disorder of participants were categorized on the basis of the judgement of the investigator as mild, moderate and severe.', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Insomnia', 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '2.45', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Insomnia', 'classes': [{'title': '< 1 year', 'categories': [{'measurements': [{'value': '1522', 'groupId': 'BG000'}]}]}, {'title': '>=1 year to <3 years', 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}]}]}, {'title': '>=3 to < 5 years', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}]}]}, {'title': '>=5 years', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1218', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presence of Complications', 'classes': [{'title': 'Had Complications', 'categories': [{'measurements': [{'value': '2618', 'groupId': 'BG000'}]}]}, {'title': 'Had No Complications', 'categories': [{'measurements': [{'value': '605', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Breakdown of complications', 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '1206', 'groupId': 'BG000'}]}]}, {'title': 'Dyslipidaemia', 'categories': [{'measurements': [{'value': '694', 'groupId': 'BG000'}]}]}, {'title': 'Mental disease', 'categories': [{'measurements': [{'value': '495', 'groupId': 'BG000'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '419', 'groupId': 'BG000'}]}]}, {'title': 'Heart or cerebrovascular disease', 'categories': [{'measurements': [{'value': '393', 'groupId': 'BG000'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}]}]}, {'title': 'Hepatobiliary disorders', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants could be counted in more than 1 category (including duplicates).', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety analysis set was defined as participants who were enrolled and completed the study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3339}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-02', 'studyFirstSubmitDate': '2014-02-07', 'resultsFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2014-02-07', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-02', 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting One or More Adverse Drug Reactions', 'timeFrame': 'Baseline up to 6 weeks', 'description': "Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug."}, {'measure': 'Number of Participants Reporting One or More Serious Adverse Drug Reactions', 'timeFrame': 'Baseline up to 6 weeks', 'description': "Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly."}], 'secondaryOutcomes': [{'measure': 'Sleep Status: Sleep Onset Latency', 'timeFrame': 'Baseline and Week 4', 'description': 'Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset.'}, {'measure': 'Sleep Status: Total Sleep Time', 'timeFrame': 'Baseline and Week 4', 'description': 'Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.'}, {'measure': 'Sleep Status: Number of Awakenings', 'timeFrame': 'Baseline and Week 4', 'description': 'Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation.'}, {'measure': 'Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4', 'timeFrame': 'Week 4', 'description': 'PGI is a participant rated instrument to measure participant\'s change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.', 'detailedDescription': 'This is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000)\n\nThe usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Insomnia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Sleep-onset difficulty associated with insomnia\n\nExclusion Criteria:\n\n1. Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets\n2. Patients with severe liver dysfunction\n3. Patients taking fluvoxamine maleate'}, 'identificationModule': {'nctId': 'NCT02058992', 'briefTitle': 'Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty', 'orgStudyIdInfo': {'id': '293-101'}, 'secondaryIdInfos': [{'id': 'JapicCTI-132358', 'type': 'REGISTRY', 'domain': 'JapicCTI'}, {'id': 'JapicCTI-R150751', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ramelteon 8 mg administered orally once daily', 'interventionNames': ['Drug: Ramelteon']}], 'interventions': [{'name': 'Ramelteon', 'type': 'DRUG', 'otherNames': ['Rozerem'], 'description': 'Ramelteon 8 mg tablets', 'armGroupLabels': ['Ramelteon 8 mg administered orally once daily']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Postmarketing Group Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}