Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03209518
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2017-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, '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': 'Up to Week 24', '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 survey treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.', 'otherNumAtRisk': 310, 'deathsNumAtRisk': 310, 'otherNumAffected': 20, 'seriousNumAtRisk': 310, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 21.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 21.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 21.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 21.1'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had One or More Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.45', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as participants who were evaluable for the safety without major protocol deviation within those who administered the survey drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had One or More Adverse Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'Adverse drug reaction refers to adverse events related to the administered drug.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as participants who were evaluable for the safety without major protocol deviation within those who administered the survey drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '312'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Case Report Forms Uncollected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the survey at 52 investigative sites in Japan, from 18 March 2016 to 10 October 2018.', 'preAssignmentDetails': 'Participants with a historical diagnosis of premenopausal breast cancer were enrolled. Participants received Leuprorelin as part of routine medical care.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43.8', 'spread': '5.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '310', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '310', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Duration between Diagnosis of Premenopausal Breast Cancer and Survey Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.80', 'spread': '20.777', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mean duration between the first diagnosis of premenopausal breast cancer and the start of the survey was reported.', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '302', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with each score of ECOG Performance Status at the survey start was reported. Following are ECOG grades. 0:Fully active, perform all pre-disease activities without restriction. 1:Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2:Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (\\>) 50% of waking hours. 3:Capable of limited self-care, confined to bed or chair \\>50% of waking hours. 4:Completely disabled, not capable of any self-care, totally confined to bed or chair.', 'unitOfMeasure': 'Participants'}, {'title': 'Target of Treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Participants with Neoadjuvant Therapy', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Participants with Adjuvant Therapy', 'measurements': [{'value': '272', 'groupId': 'BG000'}]}, {'title': 'Participants with Progressive Breast Cancer', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Participants with Recurrent Breast Cancer', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Hormone Receptor Expression', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '310', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Healthcare Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Outpatient', 'measurements': [{'value': '308', 'groupId': 'BG000'}]}, {'title': 'Inpatient', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were categorized as outpatient and inpatient.', 'unitOfMeasure': 'Participants'}, {'title': 'Predisposition to Hypersensitivity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had No Predisposition to Hypersensitivity', 'measurements': [{'value': '282', 'groupId': 'BG000'}]}, {'title': 'Had Predisposition to Hypersensitivity', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical Complications', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had No Medical Complications', 'measurements': [{'value': '267', 'groupId': 'BG000'}]}, {'title': 'Had Medical Complications', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History of Thromboembolism', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had No Medical History of Thromboembolism', 'measurements': [{'value': '307', 'groupId': 'BG000'}]}, {'title': 'Had Medical History of Thromboembolism', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with or without medical history of thromboembolism was reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '159.4', 'spread': '5.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55.55', 'spread': '10.650', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21.86', 'spread': '3.952', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/meter(m)^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Prior Treatment with LH-RH Agonists', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not Treated with Drugs', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}, {'title': 'Treated with LH-RH Agonists', 'measurements': [{'value': '233', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who were treated or were not treated with LH-RH agonists for premenopausal breast cancer was reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Treatment with Drugs for Premenopausal Breast Cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not Treated with Drugs', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Treated with Drugs', 'measurements': [{'value': '263', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who were treated or were not treated with drugs except LH-RH agonists for premenopausal breast cancer was reported.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as participants who were evaluable for the safety without major protocol deviation within those who administered the survey drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-05', 'size': 758875, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-09T01:33', 'hasProtocol': True}, {'date': '2019-04-04', 'size': 572019, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-09T01:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-09', 'studyFirstSubmitDate': '2017-07-04', 'resultsFirstSubmitDate': '2019-10-09', 'studyFirstSubmitQcDate': '2017-07-04', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-09', 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Had One or More Adverse Events', 'timeFrame': 'Up to Week 24'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Had One or More Adverse Reactions', 'timeFrame': 'Up to Week 24', 'description': 'Adverse drug reaction refers to adverse events related to the administered drug.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premenopausal Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.', 'detailedDescription': 'The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer.\n\nThis survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.\n\nThe survey will enroll approximately 300 patients.\n\n\\- Leuprorelin\n\nThis multi-center survey will be conducted in Japan.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The survey population will consist of participants with a diagnosis of premenopausal breast cancer and received dose of Leuprorelin for Injection Kit 22.5 mg in the routine medical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Participants with premenopausal breast cancer will be included.\n\nExclusion Criteria:\n\n* Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues\n* Pregnant or potentially pregnant participants and breastfeeding participants'}, 'identificationModule': {'nctId': 'NCT03209518', 'briefTitle': 'Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"', 'orgStudyIdInfo': {'id': 'Leuprorelin-5003'}, 'secondaryIdInfos': [{'id': 'JapicCTI-163203', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Leuprorelin acetate', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.', 'interventionNames': ['Drug: Leuprorelin acetate']}], 'interventions': [{'name': 'Leuprorelin acetate', 'type': 'DRUG', 'otherNames': ['Leuplin PRO for Injection Kit 22.5 mg'], 'description': 'Leuplin PRO for Injection Kit 22.5 mg', 'armGroupLabels': ['Leuprorelin acetate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Takeda selected site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}