Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT01637935
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2012-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Head, Pharmacoepidemiology', '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 45 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': {'description': 'Adverse events not applicable as this study is based on the secondary use of electronic medical records.', 'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone Exposed Group', 'description': 'Patients ever exposed to pioglitazone.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pioglitazone Unexposed Group', 'description': 'Patients never exposed to pioglitazone.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incident Diagnosis of Bladder Cancer (10-year Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34181', 'groupId': 'OG000'}, {'value': '158918', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Exposed Group', 'description': 'Patients ever exposed to pioglitazone.'}, {'id': 'OG001', 'title': 'Pioglitazone Unexposed Group', 'description': 'Patients never exposed to pioglitazone.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000', 'lowerLimit': '76.9', 'upperLimit': '102.7'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '71.3', 'upperLimit': '80.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.31', 'groupDescription': 'Fully adjusted refers to inclusion of all potential confounders in the statistical model from the 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder cancer, renal insufficiency, HbA1c and the interaction with new diagnosis of diabetes, duration of diabetes, and year of cohort entry.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.26', 'groupDescription': 'Fully adjusted adding the proteinuria testing variable.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'January 1, 1997 to December 31, 2012', 'description': 'Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.', 'unitOfMeasure': 'events per 100,000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34181', 'groupId': 'OG000'}, {'value': '158918', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Exposed Group', 'description': 'Patients ever exposed to pioglitazone.'}, {'id': 'OG001', 'title': 'Pioglitazone Unexposed Group', 'description': 'Patients never exposed to pioglitazone.'}], 'classes': [{'title': 'Less than 4.5 years', 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '82.5'}, {'value': 'NA', 'comment': 'Not calculated for the No Pioglitazone Treatment group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '4.5 -8.5 years', 'categories': [{'measurements': [{'value': '111.6', 'groupId': 'OG000', 'lowerLimit': '84.5', 'upperLimit': '138.7'}, {'value': 'NA', 'comment': 'Not calculated for the No Pioglitazone Treatment group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'More than 8.0 years', 'categories': [{'measurements': [{'value': '125.8', 'groupId': 'OG000', 'lowerLimit': '82.9', 'upperLimit': '168.7'}, {'value': 'NA', 'comment': 'Not calculated for the No Pioglitazone Treatment group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.12', 'groupDescription': 'Time since starting pioglitazone \\<4.5 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.59', 'groupDescription': 'Time since starting pioglitazone 4.5-8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.75', 'groupDescription': 'Time since starting pioglitazone \\>8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'January 1, 1997 to December 31, 2012', 'unitOfMeasure': 'events per 100,000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34181', 'groupId': 'OG000'}, {'value': '158918', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Exposed Group', 'description': 'Patients ever exposed to pioglitazone.'}, {'id': 'OG001', 'title': 'Pioglitazone Unexposed Group', 'description': 'Patients never exposed to pioglitazone.'}], 'classes': [{'title': 'Less than 1.5 years', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '84.6'}, {'value': 'NA', 'comment': 'Not calculated for the No Pioglitazone Treatment group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '1.5 - 4.0 years', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '109.3'}, {'value': 'NA', 'comment': 'Not calculated for the No Pioglitazone Treatment group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'More than 4 years', 'categories': [{'measurements': [{'value': '113.7', 'groupId': 'OG000', 'lowerLimit': '84.2', 'upperLimit': '143.2'}, {'value': 'NA', 'comment': 'Not calculated for the No Pioglitazone Treatment group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.16', 'groupDescription': 'Duration of therapy \\<1.5 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.33', 'groupDescription': 'Duration of therapy 1.5-4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.54', 'groupDescription': 'Duration of therapy \\>4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'January 1, 1997 to December 31, 2012', 'unitOfMeasure': 'events per 100,000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34181', 'groupId': 'OG000'}, {'value': '158918', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Exposed Group', 'description': 'Patients ever exposed to pioglitazone.'}, {'id': 'OG001', 'title': 'Pioglitazone Unexposed Group', 'description': 'Patients never exposed to pioglitazone.'}], 'classes': [{'title': '1 - 14000 mg', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '52.4', 'upperLimit': '85.8'}, {'value': 'NA', 'comment': 'Not calculated for the No Pioglitazone Treatment group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '14001 - 40000 mg', 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '119.8'}, {'value': 'NA', 'comment': 'Not calculated for the No Pioglitazone Treatment group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '>40000 mg', 'categories': [{'measurements': [{'value': '101.4', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '129.2'}, {'value': 'NA', 'comment': 'Not calculated for the No Pioglitazone Treatment group.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.16', 'groupDescription': 'Cumulative dose 1-14000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.42', 'groupDescription': 'Cumulative dose 14001-40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.44', 'groupDescription': 'Cumulative dose \\>40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'January 1, 1997 to December 31, 2012', 'unitOfMeasure': 'events per 100,000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Stage of Bladder Cancer (10 Year Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '1075', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Exposed Group', 'description': 'Patients ever exposed to pioglitazone.'}, {'id': 'OG001', 'title': 'Pioglitazone Unexposed Group', 'description': 'Patients never exposed to pioglitazone.'}], 'classes': [{'title': 'PUNLMP', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'In situ', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Local', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Regional', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Distant', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Undetermined', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'January 1, 1997 to December 31, 2012', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants diagnosed with bladder cancer.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone Exposed Group', 'description': 'Patients ever exposed to pioglitazone.'}, {'id': 'FG001', 'title': 'Pioglitazone Unexposed Group', 'description': 'Patients never exposed to pioglitazone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34181'}, {'groupId': 'FG001', 'numSubjects': '158918'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34181'}, {'groupId': 'FG001', 'numSubjects': '158918'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Not applicable (database study)', 'preAssignmentDetails': 'Not applicable (database study)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34181', 'groupId': 'BG000'}, {'value': '158918', 'groupId': 'BG001'}, {'value': '193099', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone Exposed Group', 'description': 'Patients ever exposed to pioglitazone.'}, {'id': 'BG001', 'title': 'Pioglitazone Unexposed Group', 'description': 'Patients never exposed to pioglitazone.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '40-49 years', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'BG000'}, {'value': '22.1', 'groupId': 'BG001'}, {'value': '51.3', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'BG000'}, {'value': '25.6', 'groupId': 'BG001'}, {'value': '58.6', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'BG000'}, {'value': '26.2', 'groupId': 'BG001'}, {'value': '51.9', 'groupId': 'BG002'}]}]}, {'title': '70 years and older', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'BG000'}, {'value': '26.1', 'groupId': 'BG001'}, {'value': '38.1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'BG000'}, {'value': '46.5', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'BG000'}, {'value': '53.5', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'BG000'}, {'value': '52.3', 'groupId': 'BG001'}, {'value': '103.6', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'BG000'}, {'value': '10.8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'BG000'}, {'value': '12.8', 'groupId': 'BG001'}, {'value': '27.6', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'BG000'}, {'value': '10.6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'BG000'}, {'value': '5.7', 'groupId': 'BG001'}, {'value': '11.6', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'BG000'}, {'value': '7.8', 'groupId': 'BG001'}, {'value': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Current smoker', 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'groupId': 'BG000'}, {'value': '17.4', 'groupId': 'BG001'}, {'value': '37.8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Renal function at baseline', 'classes': [{'title': 'Normal creatinine', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'BG000'}, {'value': '77.1', 'groupId': 'BG001'}, {'value': '154.5', 'groupId': 'BG002'}]}]}, {'title': 'Elevated creatinine', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'BG000'}, {'value': '8.7', 'groupId': 'BG001'}, {'value': '12.7', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'BG000'}, {'value': '14.1', 'groupId': 'BG001'}, {'value': '32.7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Elevated creatinine: Creatinine \\>1.4 mg/dL for women and \\>1.5 mg/dL for men.', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Congestive heart failure at baseline', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'BG000'}, {'value': '6.9', 'groupId': 'BG001'}, {'value': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Baseline Glycosylated Hemoglobin (HbA1c)', 'classes': [{'title': '<7%', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'BG000'}, {'value': '28.6', 'groupId': 'BG001'}, {'value': '45.7', 'groupId': 'BG002'}]}]}, {'title': '7-7.9%', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'BG000'}, {'value': '19.3', 'groupId': 'BG001'}, {'value': '37.6', 'groupId': 'BG002'}]}]}, {'title': '8-8.9%', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'BG000'}, {'value': '10.4', 'groupId': 'BG001'}, {'value': '23.2', 'groupId': 'BG002'}]}]}, {'title': '9-9.9%', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'BG000'}, {'value': '7.0', 'groupId': 'BG001'}, {'value': '16.7', 'groupId': 'BG002'}]}]}, {'title': '≥10%', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'BG000'}, {'value': '17.1', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'BG000'}, {'value': '17.5', 'groupId': 'BG001'}, {'value': '35.6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Newly diagnosed with diabetes mellitus at the start of follow-up', 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'groupId': 'BG000'}, {'value': '57.9', 'groupId': 'BG001'}, {'value': '108.7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Includes newly diagnosed patients and patients who newly enrolled in Kaiser Permanente with an existing diagnosis of diabetes mellitus.', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Diabetes duration at baseline', 'classes': [{'title': '0-4 years', 'categories': [{'measurements': [{'value': '60.1', 'groupId': 'BG000'}, {'value': '62.8', 'groupId': 'BG001'}, {'value': '122.9', 'groupId': 'BG002'}]}]}, {'title': '5-9 years', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'BG000'}, {'value': '6.0', 'groupId': 'BG001'}, {'value': '15.2', 'groupId': 'BG002'}]}]}, {'title': '10 or more years', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'BG000'}, {'value': '10.9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'BG000'}, {'value': '20.4', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Other cancer prior to baseline', 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'BG000'}, {'value': '5.3', 'groupId': 'BG001'}, {'value': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Other diabetes medications', 'classes': [{'title': 'Other thiazolidinediones', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'BG000'}, {'value': '1.5', 'groupId': 'BG001'}, {'value': '9.7', 'groupId': 'BG002'}]}]}, {'title': 'Metformin', 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'BG000'}, {'value': '45.9', 'groupId': 'BG001'}, {'value': '130.7', 'groupId': 'BG002'}]}]}, {'title': 'Sulfonylureas', 'categories': [{'measurements': [{'value': '89.8', 'groupId': 'BG000'}, {'value': '61.2', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}, {'title': 'Other oral hypoglycemic drugs', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'BG000'}, {'value': '1.4', 'groupId': 'BG001'}, {'value': '7.8', 'groupId': 'BG002'}]}]}, {'title': 'Insulin', 'categories': [{'measurements': [{'value': '52.7', 'groupId': 'BG000'}, {'value': '29.4', 'groupId': 'BG001'}, {'value': '82.1', 'groupId': 'BG002'}]}]}, {'title': 'Never treated with any diabetes medication', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'BG000'}, {'value': '14.3', 'groupId': 'BG001'}, {'value': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Includes use of any other diabetes medications during follow-up.', 'unitOfMeasure': 'percentage of participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193099}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2012-07-07', 'resultsFirstSubmitDate': '2012-08-31', 'studyFirstSubmitQcDate': '2012-07-07', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-08-31', 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incident Diagnosis of Bladder Cancer (10-year Analysis)', 'timeFrame': 'January 1, 1997 to December 31, 2012', 'description': 'Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.'}], 'secondaryOutcomes': [{'measure': 'Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)', 'timeFrame': 'January 1, 1997 to December 31, 2012'}, {'measure': 'Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)', 'timeFrame': 'January 1, 1997 to December 31, 2012'}, {'measure': 'Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)', 'timeFrame': 'January 1, 1997 to December 31, 2012'}, {'measure': 'Stage of Bladder Cancer (10 Year Analysis)', 'timeFrame': 'January 1, 1997 to December 31, 2012'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Diabetes', 'Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '21447663', 'type': 'RESULT', 'citation': 'Lewis JD, Ferrara A, Peng T, Hedderson M, Bilker WB, Quesenberry CP Jr, Vaughn DJ, Nessel L, Selby J, Strom BL. Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. Diabetes Care. 2011 Apr;34(4):916-22. doi: 10.2337/dc10-1068.'}, {'pmid': '26197187', 'type': 'RESULT', 'citation': 'Lewis JD, Habel LA, Quesenberry CP, Strom BL, Peng T, Hedderson MM, Ehrlich SF, Mamtani R, Bilker W, Vaughn DJ, Nessel L, Van Den Eeden SK, Ferrara A. Pioglitazone Use and Risk of Bladder Cancer and Other Common Cancers in Persons With Diabetes. JAMA. 2015 Jul 21;314(3):265-77. doi: 10.1001/jama.2015.7996.'}], 'seeAlsoLinks': [{'url': 'http://general.takedapharm.com/content/file/pi.pdf?applicationcode=ab2d7112-8eb3-465a-8fda-35018a9eafb0&fileTypeCode=ACTOSPI', 'label': 'ACTOS® Package Insert'}, {'url': 'https://www.takeda.com/siteassets/en-us/home/external-reference/clinicaltrials.gov/01-03-tl-opi-524-10-year_final_report.pdf', 'label': '10-Year Final Report'}]}, 'descriptionModule': {'briefSummary': 'To assess the potential association between pioglitazone and bladder cancer compared with non-pioglitazone users among patients with type 2 diabetes mellitus.', 'detailedDescription': 'Following guidance from the United States Food and Drug Administration (FDA) and European Medicines Agency, the University of Pennsylvania and Kaiser Permanente Northern California (KPNC) designed and conducted this study using the KPNC database to assess the potential association between pioglitazone and bladder cancer among patients with type 2 diabetes mellitus.\n\nThe study was conducted over the course of 10 years, with a series of interim analyses undertaken during this period and provided to the sponsor (Takeda) and the appropriate regulatory agencies.\n\nIn 2011, the planned 5-year interim analysis of this study was published in Diabetes Care. That report included data from 1 January 1997 to 30 April 2008. Following reporting of these data, there was a request from the FDA for an additional fourth interim analysis at 8 years including data from 1 January 1997 to 31 December 2010.\n\nIn August 2011 the FDA requested inclusion of a sensitivity analysis to assess change of cohort entry criteria to minimize left censoring of exposure. Included in the FDA request was a duration analysis for other antidiabetic medications.\n\nIn August 2014, the final 10-year analyses were completed and submitted to the sponsor and regulatory agencies.\n\nInterim results previously posted on clinicaltrials.gov are available in the public archive'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study was conducted within Kaiser Permanente Northern California (KPNC), which provides comprehensive healthcare services to approximately 3.2 million members. The source population was identified from the KPNC diabetes registry, which was first constructed in 1993 and has been updated annually since then. The registry identifies patients primarily from four data sources: primary hospital discharge diagnoses of diabetes mellitus (since 1971); two or more outpatient visit diagnoses of diabetes (since 1995); any prescription for a diabetes-related medication (since 1994); or any record of an abnormal hemoglobin A1c (HbA1c) test (\\>6.7%) (since 1991).\n\nThe diabetes registry gathers data from a variety of KPNC electronic medical records (EMR) to build and follow the registry cohort across time. These data include cancer registries, pharmacy records, laboratory records, and inpatient and outpatient medical diagnoses.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study cohort included both patients with an established diagnosis of diabetes mellitus prior to January 1, 1997 and those who were newly diagnosed prior to December 31, 2002. Patients were eligible for the study cohort if they met any of the following criteria:\n\n 1. As of January 1, 1997 they had been diagnosed with diabetes mellitus, were age 40 or older and were members of KPNC,\n 2. They had been diagnosed with diabetes mellitus, reached age 40 between January 1, 1997 and December 31, 2002 and were KPNC members on their 40th birthday, or\n 3. Had diabetes mellitus and were age 40 or older when they joined KPNC between January 1, 1997 and December 31, 2002.\n\n Exclusion Criteria:\n* Diagnosis of bladder cancer recorded in the KPNC cancer registry prior to entry to the cohort or within 6 months of entry into KPNC.'}, 'identificationModule': {'nctId': 'NCT01637935', 'briefTitle': 'Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes', 'orgStudyIdInfo': {'id': '01-03-TL-OPI-524'}, 'secondaryIdInfos': [{'id': 'U1111-1132-3482', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pioglitazone exposed group', 'description': 'Defined as those patients having filled at least two prescriptions for pioglitazone within a 6-month period. Patients in the pioglitazone group may also have exposure to other diabetic medications', 'interventionNames': ['Drug: Pioglitazone']}, {'label': 'Pioglitazone unexposed group', 'description': 'Defined as patients who did not fill at least two prescriptions for pioglitazone within a 6-month period. Patients in the pioglitazone unexposed group may have been exposed to other diabetic medications. This group also included diabetic patients without any diabetic medications.'}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': 'Pioglitazone tablets.', 'armGroupLabels': ['Pioglitazone exposed group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': 'Department of Epidemiology at University of Pennsylvania', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}