Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02958956
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus.
Sponsor:
Organization:
Raw JSON
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Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Due to the observational nature of study individual adverse events (AEs) were not planned to be collected and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Ever User of Pioglitazone', 'description': 'Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Never User of Pioglitazone', 'description': 'Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236507', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.'}], 'classes': [{'title': 'Prostate', 'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.26'}]}]}, {'title': 'Breast', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '1.13'}]}]}, {'title': 'Lung/Bronchus', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.15'}]}]}, {'title': 'Colon', 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '1.05'}]}]}, {'title': 'Non-Hodgkin Lymphoma', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1.23'}]}]}, {'title': 'Corpus Uteri', 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '1.09'}]}]}, {'title': 'Pancreatic', 'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '1.71'}]}]}, {'title': 'Kidney/Renal Pelvis', 'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '1.18'}]}]}, {'title': 'Rectum', 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.60', 'upperLimit': '1.08'}]}]}, {'title': 'Melanoma', 'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '1.46'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years 5 months', 'description': 'The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with ever use of pioglitazone. 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[{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '648', 'groupId': 'OG001'}]}]}, {'title': 'Kidney/Renal Pelvis', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '690', 'groupId': 'OG001'}]}]}, {'title': 'Rectum', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}]}]}, {'title': 'Melanoma', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '594', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years 5 months', 'description': 'Number of 10 most common cancer cases are reported in this measure: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.'}, {'type': 'SECONDARY', 'title': 'Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236507', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.'}], 'classes': [{'title': 'Prostate: <12 months ago', 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.17'}]}]}, {'title': 'Prostate: 12-23 months ago', 'categories': [{'measurements': [{'value': '1.18', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.47'}]}]}, {'title': 'Prostate: 24-35 months ago', 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.52'}]}]}, {'title': 'Prostate: 36-47 months ago', 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '1.71'}]}]}, {'title': 'Prostate: 48-83 months ago', 'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '1.26'}]}]}, {'title': 'Prostate: 84+ months ago', 'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.59'}]}]}, {'title': 'Breast: <12 months ago', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '1.31'}]}]}, {'title': 'Breast: 12-23 months ago', 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '1.14'}]}]}, {'title': 'Breast: 24-35 months ago', 'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '1.39'}]}]}, {'title': 'Breast: 36-47 months ago', 'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '1.10'}]}]}, {'title': 'Breast: 48-83 months ago', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.28'}]}]}, {'title': 'Breast: 84+ months ago', 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.06', 'upperLimit': '1.80'}]}]}, {'title': 'Lung/Bronchus: <12 months ago', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.14'}]}]}, {'title': 'Lung/Bronchus: 12-23 months ago', 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.50'}]}]}, {'title': 'Lung/Bronchus: 24-35 months ago', 'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.53'}]}]}, {'title': 'Lung/Bronchus: 36-47 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{'title': 'Melanoma: 48-83 months ago', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '1.47'}]}]}, {'title': 'Melanoma: 84+ months ago', 'categories': [{'measurements': [{'value': '1.47', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '2.36'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years 5 months', 'description': 'The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. The various times since initiation include \\<12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago. Cox proportional hazards regression modeling was used to provide point and interval estimates of the time since first use. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.'}, {'type': 'SECONDARY', 'title': 'Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ever User of Pioglitazone', 'description': 'Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.'}], 'classes': [{'title': 'Prostate: <12 months ago', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 12-23 months ago', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 24-35 months ago', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 36-47 months ago', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 48-83 months ago', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 84+ months ago', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Breast: <12 months ago', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 12-23 months ago', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 24-35 months ago', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 36-47 months ago', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 48-83 months ago', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 84+ months ago', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: <12 months ago', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 12-23 months ago', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 24-35 months ago', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 36-47 months ago', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 48-83 months ago', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 84+ months ago', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Colon: <12 months ago', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 12-23 months ago', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 24-35 months ago', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 36-47 months ago', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 48-83 months ago', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 84+ months ago', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: <12 months ago', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 12-23 months ago', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 24-35 months ago', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 36-47 months ago', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 48-83 months ago', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 84+ months ago', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: <12 months ago', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 12-23 months ago', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 24-35 months ago', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 36-47 months ago', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 48-83 months ago', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 84+ months ago', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: <12 months ago', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 12-23 months ago', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 24-35 months ago', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 36-47 months ago', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 48-83 months ago', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 84+ months ago', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: <12 months ago', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 12-23 months ago', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 24-35 months ago', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 36-47 months ago', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 48-83 months ago', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 84+ months ago', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: <12 months ago', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 12-23 months ago', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 24-35 months ago', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 36-47 months ago', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 48-83 months ago', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 84+ months ago', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: <12 months ago', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 12-23 months ago', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 24-35 months ago', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 36-47 months ago', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 48-83 months ago', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 84+ months ago', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years 5 months', 'description': 'Number of 10 most common cancer cases: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. Time since initiation of pioglitazone was categorized as \\<12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236507', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.'}], 'classes': [{'title': 'Prostate: <12 months', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.19'}]}]}, {'title': 'Prostate: 12-23 months', 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.57'}]}]}, {'title': 'Prostate: 24-35 months', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.35'}]}]}, {'title': 'Prostate: 36-59 months', 'categories': [{'measurements': [{'value': '1.18', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.45'}]}]}, {'title': 'Prostate: 60+ months', 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.50'}]}]}, {'title': 'Breast: <12 months', 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '1.03'}]}]}, {'title': 'Breast: 12-23 months', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.35'}]}]}, {'title': 'Breast: 24-35 months', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '1.35'}]}]}, {'title': 'Breast: 36-59 months', 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '1.38'}]}]}, {'title': 'Breast: 60+ months', 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '1.68'}]}]}, {'title': 'Lung/Bronchus: <12 months', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.12'}]}]}, {'title': 'Lung/Bronchus: 12-23 months', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '1.27'}]}]}, {'title': 'Lung/Bronchus: 24-35 months', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '1.31'}]}]}, {'title': 'Lung/Bronchus: 36-59 months', 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1.40'}]}]}, {'title': 'Lung/Bronchus: 60+ months', 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1.54'}]}]}, {'title': 'Colon: <12 months', 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '1.08'}]}]}, {'title': 'Colon: 12-23 months', 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '1.18'}]}]}, {'title': 'Colon: 24-35 months', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '1.42'}]}]}, {'title': 'Colon: 36-59 months', 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '0.94'}]}]}, {'title': 'Colon: 60+ months', 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '1.46'}]}]}, {'title': 'Non-Hodgkin Lymphoma: <12 months', 'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '1.29'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 12-23 months', 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.80'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 24-35 months', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '1.70'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 36-59 months', 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '1.18'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 60+ months', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '1.49'}]}]}, {'title': 'Corpus Uteri: <12 months', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '1.35'}]}]}, {'title': 'Corpus Uteri: 12-23 months', 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '1.25'}]}]}, {'title': 'Corpus Uteri: 24-35 months', 'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '1.55'}]}]}, {'title': 'Corpus Uteri: 36-59 months', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '1.24'}]}]}, {'title': 'Corpus Uteri: 60+ months', 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '1.29'}]}]}, {'title': 'Pancreatic: <12 months', 'categories': [{'measurements': [{'value': '1.48', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '1.95'}]}]}, {'title': 'Pancreatic: 12-23 months', 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '1.73'}]}]}, {'title': 'Pancreatic: 24-35 months', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '1.66'}]}]}, {'title': 'Pancreatic: 36-59 months', 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '1.15', 'upperLimit': '2.31'}]}]}, {'title': 'Pancreatic: 60+ months', 'categories': [{'measurements': [{'value': '1.53', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.33'}]}]}, {'title': 'Kidney/Renal Pelvis: <12 months', 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '1.30'}]}]}, {'title': 'Kidney/Renal Pelvis: 12-23 months', 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '1.27'}]}]}, {'title': 'Kidney/Renal Pelvis: 24-35 months', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.57'}]}]}, {'title': 'Kidney/Renal Pelvis: 36-59 months', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '1.52'}]}]}, {'title': 'Kidney/Renal Pelvis: 60+ months', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '1.68'}]}]}, {'title': 'Rectum: <12 months', 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '1.33'}]}]}, {'title': 'Rectum: 12-23 months', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.45', 'upperLimit': '1.37'}]}]}, {'title': 'Rectum: 24-35 months', 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '1.56'}]}]}, {'title': 'Rectum: 36-59 months', 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '1.18'}]}]}, {'title': 'Rectum: 60+ months', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '1.82'}]}]}, {'title': 'Melanoma: <12 months', 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.54'}]}]}, {'title': 'Melanoma: 12-23 months', 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '2.33'}]}]}, {'title': 'Melanoma: 24-35 months', 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '1.81'}]}]}, {'title': 'Melanoma: 36-59 months', 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '1.37'}]}]}, {'title': 'Melanoma: 60+ months', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '2.35'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years 5 months', 'description': 'The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as \\<12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months. Cox proportional hazards regression modeling was used to provide point and interval estimates of the cumulative duration. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.'}, {'type': 'SECONDARY', 'title': 'Number of 10 Most Common Cancer Cases by Duration of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ever User of Pioglitazone', 'description': 'Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.'}], 'classes': [{'title': 'Prostate: <12 months', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 12-23 months', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 24-35 months', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 36-59 months', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 60+ months', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Breast: <12 months', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 12-23 months', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 24-35 months', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 36-59 months', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 60+ months', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: <12 months', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 12-23 months', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 24-35 months', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 36-59 months', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 60+ months', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Colon: <12 months', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 12-23 months', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 24-35 months', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 36-59 months', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 60+ months', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: <12 months', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 12-23 months', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 24-35 months', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 36-59 months', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 60+ months', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: <12 months', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 12-23 months', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 24-35 months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 36-59 months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 60+ months', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: <12 months', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 12-23 months', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 24-35 months', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 36-59 months', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 60+ months', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: <12 months', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 12-23 months', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 24-35 months', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 36-59 months', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 60+ months', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: <12 months', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 12-23 months', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 24-35 months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 36-59 months', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 60+ months', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: <12 months', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 12-23 months', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 24-35 months', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 36-59 months', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 60+ months', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years 5 months', 'description': 'The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as \\<12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236507', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.'}], 'classes': [{'title': 'Prostate: 1-9000 mg', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '1.27'}]}]}, {'title': 'Prostate: 9001-25000 mg', 'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '1.06', 'upperLimit': '1.46'}]}]}, {'title': 'Prostate: 25001-50000 mg', 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.37'}]}]}, {'title': 'Prostate: >=50001 mg', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '1.28'}]}]}, {'title': 'Breast: 1-9000 mg', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.08'}]}]}, {'title': 'Breast: 9001-25000 mg', 'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '1.17'}]}]}, {'title': 'Breast: 25001-50000 mg', 'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '1.46'}]}]}, {'title': 'Breast: >=50001 mg', 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.57'}]}]}, {'title': 'Lung/Bronchus: 1-9000 mg', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.21'}]}]}, {'title': 'Lung/Bronchus: 9001-25000 mg', 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.15'}]}]}, {'title': 'Lung/Bronchus: 25001-50000 mg', 'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '1.26'}]}]}, {'title': 'Lung/Bronchus: >=50001 mg', 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.50'}]}]}, {'title': 'Colon: 1-9000 mg', 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '1.10'}]}]}, {'title': 'Colon: 9001-25000 mg', 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '1.10'}]}]}, {'title': 'Colon: 25001-50000 mg', 'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '1.27'}]}]}, {'title': 'Colon: >=50001 mg', 'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '1.12'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 1-9000 mg', 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '1.29'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 9001-25000 mg', 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.59'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 25001-50000 mg', 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '1.51'}]}]}, {'title': 'Non-Hodgkin Lymphoma: >=50001 mg', 'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '1.13'}]}]}, {'title': 'Corpus Uteri: 1-9000 mg', 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '1.37'}]}]}, {'title': 'Corpus Uteri: 9001-25000 mg', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '1.25'}]}]}, {'title': 'Corpus Uteri: 25001-50000 mg', 'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '1.06'}]}]}, {'title': 'Corpus Uteri: >=50001 mg', 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '1.42'}]}]}, {'title': 'Pancreatic: 1-9000 mg', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.14', 'upperLimit': '1.98'}]}]}, {'title': 'Pancreatic: 9001-25000 mg', 'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '1.53'}]}]}, {'title': 'Pancreatic: 25001-50000 mg', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '1.04', 'upperLimit': '2.06'}]}]}, {'title': 'Pancreatic: >=50001 mg', 'categories': [{'measurements': [{'value': '1.61', 'groupId': 'OG000', 'lowerLimit': '1.10', 'upperLimit': '2.35'}]}]}, {'title': 'Kidney/Renal Pelvis: 1-9000 mg', 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '1.19'}]}]}, {'title': 'Kidney/Renal Pelvis: 9001-25000 mg', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.44'}]}]}, {'title': 'Kidney/Renal Pelvis: 25001-50000 mg', 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '1.32'}]}]}, {'title': 'Kidney/Renal Pelvis: >=50001 mg', 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.64'}]}]}, {'title': 'Rectum: 1-9000 mg', 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '1.30'}]}]}, {'title': 'Rectum: 9001-25000 mg', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '1.23'}]}]}, {'title': 'Rectum: 25001-50000 mg', 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '1.34'}]}]}, {'title': 'Rectum: >=50001 mg', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '1.61'}]}]}, {'title': 'Melanoma: 1-9000 mg', 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.72'}]}]}, {'title': 'Melanoma: 9001-25000 mg', 'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '1.81'}]}]}, {'title': 'Melanoma: 25001-50000 mg', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '1.62'}]}]}, {'title': 'Melanoma: >=50001 mg', 'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '1.85'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years 5 months', 'description': 'The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 milligram (mg) and greater than or equal to (\\>=) 50001 mg. Cox proportional hazards regression modeling was used to provide point and interval estimates of the dose. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.'}, {'type': 'SECONDARY', 'title': 'Number of 10 Most Common Cancer Cases By Dose of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38190', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ever User of Pioglitazone', 'description': 'Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.'}], 'classes': [{'title': 'Prostate: 1-9000 mg', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 9001-25000 mg', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: 25001-50000 mg', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}, {'title': 'Prostate: >=50001 mg', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 1-9000 mg', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 9001-25000 mg', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Breast: 25001-50000 mg', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Breast: >=50001 mg', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 1-9000 mg', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 9001-25000 mg', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: 25001-50000 mg', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Lung/Bronchus: >=50001 mg', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 1-9000 mg', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 9001-25000 mg', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Colon: 25001-50000 mg', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Colon: >=50001 mg', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 1-9000 mg', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 9001-25000 mg', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: 25001-50000 mg', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Non-Hodgkin Lymphoma: >=50001 mg', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 1-9000 mg', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 9001-25000 mg', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: 25001-50000 mg', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Corpus Uteri: >=50001 mg', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 1-9000 mg', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 9001-25000 mg', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: 25001-50000 mg', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic: >=50001 mg', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 1-9000 mg', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 9001-25000 mg', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: 25001-50000 mg', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Kidney/Renal Pelvis: >=50001 mg', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 1-9000 mg', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 9001-25000 mg', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: 25001-50000 mg', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Rectum: >=50001 mg', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 1-9000 mg', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 9001-25000 mg', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: 25001-50000 mg', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Melanoma: >=50001 mg', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 years 5 months', 'description': 'The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 mg and \\>=50001 mg.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.The unexposed arm was not planned to be analyzed for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ever User of Pioglitazone', 'description': 'Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.'}, {'id': 'FG001', 'title': 'Never User of Pioglitazone', 'description': 'Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38190'}, {'groupId': 'FG001', 'numSubjects': '198317'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38190'}, {'groupId': 'FG001', 'numSubjects': '198317'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 2 investigative sites in the United States from 01 July 1997 to 30 June 2012.', 'preAssignmentDetails': 'Participants with a historical diagnosis of T2DM with pioglitazone exposure identified from the Kaiser Permanente of Northern California(KPNC) Diabetes Registry were enrolled in this observational study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38190', 'groupId': 'BG000'}, {'value': '198317', 'groupId': 'BG001'}, {'value': '236507', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ever User of Pioglitazone', 'description': 'Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.'}, {'id': 'BG001', 'title': 'Never User of Pioglitazone', 'description': 'Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '59.7', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17632', 'groupId': 'BG000'}, {'value': '92552', 'groupId': 'BG001'}, {'value': '110184', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20558', 'groupId': 'BG000'}, {'value': '105765', 'groupId': 'BG001'}, {'value': '126323', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic white', 'categories': [{'measurements': [{'value': '18717', 'groupId': 'BG000'}, {'value': '99641', 'groupId': 'BG001'}, {'value': '118358', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '3667', 'groupId': 'BG000'}, {'value': '19931', 'groupId': 'BG001'}, {'value': '23598', 'groupId': 'BG002'}]}]}, {'title': 'Asian or Pacific Islander', 'categories': [{'measurements': [{'value': '5695', 'groupId': 'BG000'}, {'value': '26637', 'groupId': 'BG001'}, {'value': '32332', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '5144', 'groupId': 'BG000'}, {'value': '21554', 'groupId': 'BG001'}, {'value': '26698', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2129', 'groupId': 'BG000'}, {'value': '10549', 'groupId': 'BG001'}, {'value': '12678', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2838', 'groupId': 'BG000'}, {'value': '20005', 'groupId': 'BG001'}, {'value': '22843', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking', 'classes': [{'title': 'Current smoking', 'categories': [{'measurements': [{'value': '7929', 'groupId': 'BG000'}, {'value': '37401', 'groupId': 'BG001'}, {'value': '45330', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '30261', 'groupId': 'BG000'}, {'value': '160916', 'groupId': 'BG001'}, {'value': '191177', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Income', 'classes': [{'title': 'Low', 'categories': [{'measurements': [{'value': '20379', 'groupId': 'BG000'}, {'value': '107007', 'groupId': 'BG001'}, {'value': '127386', 'groupId': 'BG002'}]}]}, {'title': 'High', 'categories': [{'measurements': [{'value': '17125', 'groupId': 'BG000'}, {'value': '86384', 'groupId': 'BG001'}, {'value': '103509', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '686', 'groupId': 'BG000'}, {'value': '4926', 'groupId': 'BG001'}, {'value': '5612', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Income was categorized as high and low based on whether the annual household income lied above or below the average census block median income for the cohort (59,000 US Dollars).', 'unitOfMeasure': 'Participants'}, {'title': 'Renal function', 'classes': [{'title': 'Normal creatinine', 'categories': [{'measurements': [{'value': '29476', 'groupId': 'BG000'}, {'value': '156510', 'groupId': 'BG001'}, {'value': '185986', 'groupId': 'BG002'}]}]}, {'title': 'Elevated creatinine', 'categories': [{'measurements': [{'value': '1495', 'groupId': 'BG000'}, {'value': '16234', 'groupId': 'BG001'}, {'value': '17729', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '7219', 'groupId': 'BG000'}, {'value': '25573', 'groupId': 'BG001'}, {'value': '32792', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Renal function was measured based on the levels of creatinine: normal creatinine (less than \\[\\<\\] 1.5 milligram per deciliter \\[mg/dL\\] for males and \\<1.4 mg/dL for females) and elevated creatinine (greater than or equal to \\[\\>=\\] 1.5 mg/dL for males and \\>=1.4 mg/dL for females).', 'unitOfMeasure': 'Participants'}, {'title': 'Congestive Heart Failure', 'classes': [{'title': 'Congestive Heart Failure', 'categories': [{'measurements': [{'value': '1070', 'groupId': 'BG000'}, {'value': '12602', 'groupId': 'BG001'}, {'value': '13672', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '37120', 'groupId': 'BG000'}, {'value': '185715', 'groupId': 'BG001'}, {'value': '222835', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Glycosylated Hemoglobin (HbA1c)', 'classes': [{'title': '<7.0 percent (%)', 'categories': [{'measurements': [{'value': '6832', 'groupId': 'BG000'}, {'value': '63867', 'groupId': 'BG001'}, {'value': '70699', 'groupId': 'BG002'}]}]}, {'title': '7.0-7.9%', 'categories': [{'measurements': [{'value': '6594', 'groupId': 'BG000'}, {'value': '34579', 'groupId': 'BG001'}, {'value': '41173', 'groupId': 'BG002'}]}]}, {'title': '8.0-8.9%', 'categories': [{'measurements': [{'value': '4514', 'groupId': 'BG000'}, {'value': '17971', 'groupId': 'BG001'}, {'value': '22485', 'groupId': 'BG002'}]}]}, {'title': '9.0-9.9%', 'categories': [{'measurements': [{'value': '3451', 'groupId': 'BG000'}, {'value': '12342', 'groupId': 'BG001'}, {'value': '15793', 'groupId': 'BG002'}]}]}, {'title': '>=10.0%', 'categories': [{'measurements': [{'value': '8390', 'groupId': 'BG000'}, {'value': '29836', 'groupId': 'BG001'}, {'value': '38226', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '8409', 'groupId': 'BG000'}, {'value': '39722', 'groupId': 'BG001'}, {'value': '48131', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Time since diabetes diagnosis', 'classes': [{'title': '0-4 years', 'categories': [{'measurements': [{'value': '22835', 'groupId': 'BG000'}, {'value': '134209', 'groupId': 'BG001'}, {'value': '157044', 'groupId': 'BG002'}]}]}, {'title': '5-9 years', 'categories': [{'measurements': [{'value': '3148', 'groupId': 'BG000'}, {'value': '9554', 'groupId': 'BG001'}, {'value': '12702', 'groupId': 'BG002'}]}]}, {'title': '>= 10 years', 'categories': [{'measurements': [{'value': '2993', 'groupId': 'BG000'}, {'value': '17300', 'groupId': 'BG001'}, {'value': '20293', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '9214', 'groupId': 'BG000'}, {'value': '37254', 'groupId': 'BG001'}, {'value': '46468', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Population consisted of Type 2 diabetes mellitus (T2DM) participants who were identified from the Kaiser Diabetes Registry, were included in the membership database, medication benefit database, hospitalization and surgery procedures databases, cancer registry database merged along with data in the diabetes registry were evaluable for analysis.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236507}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2016-11-04', 'resultsFirstSubmitDate': '2016-11-12', 'studyFirstSubmitQcDate': '2016-11-04', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-12', 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone', 'timeFrame': '15 years 5 months', 'description': 'The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with ever use of pioglitazone. Cox proportional hazards regression modeling was used to provide point and interval estimates of the relative hazard of the 10 most common cancers associated with ever use of pioglitazone. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.'}, {'measure': 'Number of 10 Most Common Cancers Associated Cases', 'timeFrame': '15 years 5 months', 'description': 'Number of 10 most common cancer cases are reported in this measure: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma.'}], 'secondaryOutcomes': [{'measure': 'Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone', 'timeFrame': '15 years 5 months', 'description': 'The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. The various times since initiation include \\<12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago. Cox proportional hazards regression modeling was used to provide point and interval estimates of the time since first use. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.'}, {'measure': 'Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone', 'timeFrame': '15 years 5 months', 'description': 'Number of 10 most common cancer cases: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. Time since initiation of pioglitazone was categorized as \\<12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago.'}, {'measure': 'Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone', 'timeFrame': '15 years 5 months', 'description': 'The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as \\<12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months. Cox proportional hazards regression modeling was used to provide point and interval estimates of the cumulative duration. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.'}, {'measure': 'Number of 10 Most Common Cancer Cases by Duration of Pioglitazone', 'timeFrame': '15 years 5 months', 'description': 'The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as \\<12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months.'}, {'measure': 'Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone', 'timeFrame': '15 years 5 months', 'description': 'The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 milligram (mg) and greater than or equal to (\\>=) 50001 mg. Cox proportional hazards regression modeling was used to provide point and interval estimates of the dose. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.'}, {'measure': 'Number of 10 Most Common Cancer Cases By Dose of Pioglitazone', 'timeFrame': '15 years 5 months', 'description': 'The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 mg and \\>=50001 mg.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Diabetes Mellitus, Type 2, Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.takeda.com/siteassets/en-us/home/external-reference/clinicaltrials.gov/ad-4833-403-fum_35.4_kpnc_interim_results_report-2011-12-07.pdf', 'label': 'Interim Results Report'}, {'url': 'https://www.takeda.com/siteassets/en-us/home/external-reference/clinicaltrials.gov/ad4833-403_kpnc_10_common_cancers_10-yr_study_report.pdf', 'label': '10 yr Study Report'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate whether treatment with pioglitazone is associated with risk of incident cancer at the 10 most common sites in a cohort of participants with recognized diabetes.', 'detailedDescription': 'The study enroll a large population of approximately 252467 participants. The study would analyze association of cancer and pioglitazone in 2 cohorts based on the usage of pioglitazone. Participants in were originally planned to be followed-up from January 1, 1997 to December 31, 2005. Based on the discussion with advisory board, it was recommended to increase the study population and duration of follow-up. The follow-up period was extended to June 30, 2012 for the study.\n\nThis multi-center trial was conducted in the United States of America. The overall time to participate in this study was approximately 15.5 years. Participants were followed-up from January 1, 1997 up to June 30, 2012 for the assessment of cancer risk associated with pioglitazone use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a historical diagnosis of Type 2 diabetes mellitus (T2DM) with pioglitazone exposure identified from the Kaiser Permanente of Northern California(KPNC) Diabetes Registry (with or without diabetes) and had completed Member Health Survey (MHS) were enrolled in the epidemiology study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. has been in the KPNC diabetes registry Diabetes Mellitus (DM) registry, aged 40 years or older and are members of KPNC as of January 1, 1997, or\n2. has been in the DM registry, reached aged 40 years between January 1, 1997 and June 30, 2005 and are KPNC members on their 40th birthday, or\n3. has joined KPNC after January 1, 1997, aged 40 years or older when they are identified by the DM registry between January 1, 1997 and June 30, 2005.\n\nExclusion Criteria: 1. Age less than (\\<) 40 years during study period. 2. No KPNC medication benefits at the time of entry into the cohort (baseline) or gap in medication benefit greater than equal to (\\>=) 4 months that started in the first 4 months after entering in the cohort.\n\n3\\. Gap in KPNC membership \\>= 4 months that started in the first 4 months after entering in the cohort.\n\n4\\. Participant with a diagnosis of Human immunodeficiency virus (HIV). 5. Participants with evidence of selected surgeries for some cancer sites. 6. All prevalent cancers at baseline, that is, all participants ever diagnosed with cancer other than non-melanoma skin cancer.'}, 'identificationModule': {'nctId': 'NCT02958956', 'briefTitle': 'Cohort Study of Pioglitazone and Cancer Incidence in Participants With Diabetes Mellitus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Cohort Study of Pioglitazone and Cancer Incidence in Patients With Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'AD-4833_403A'}, 'secondaryIdInfos': [{'id': 'EUPAS10335', 'type': 'REGISTRY', 'domain': 'EU PAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ever User of Pioglitazone', 'description': 'Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.', 'interventionNames': ['Drug: Pioglitazone']}, {'label': 'Never User of Pioglitazone', 'description': 'Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.'}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'description': 'Participants with diabetes who were members of the KPNC registry, and had received at least 2 prescriptions for pioglitazone within a 6-month period were followed up to 15.5 years (1997-2012) in this observational study 1.', 'armGroupLabels': ['Ever User of Pioglitazone']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}