Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT05870956
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2023-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study limitations included: the data source was composed of administrative claims; the adherence exposure was based on prescription fill data; the outcomes were measured contemporaneously with nintedanib adherence; the outcomes consisted of inpatient hospitalization and total medical spending; the early-poor adherence group consisted of a smaller sample; sample selection bias due to the time frame chosen for patient selection; COVID-19 might have impacted health care consumption patterns.'}}, 'adverseEventsModule': {'description': 'As this is a non-interventional study with secondary use of data retrieved from Medicare administrative claims, safety monitoring and safety reporting on an individual case level is not applicable. All-Cause Mortality, Serious Adverse Events and Other Adverse Events are not collected in the database. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'High Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Moderate Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High-then-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Delayed-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Early-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total All-cause Medical Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '781', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '255', 'groupId': 'OG003'}, {'value': '370', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'High Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'OG001', 'title': 'Moderate Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'OG002', 'title': 'High-then-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline.'}, {'id': 'OG003', 'title': 'Delayed-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline.'}, {'id': 'OG004', 'title': 'Early-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline.'}], 'classes': [{'categories': [{'measurements': [{'value': '12647.73', 'spread': '16996', 'groupId': 'OG000'}, {'value': '13580.61', 'spread': '18479', 'groupId': 'OG001'}, {'value': '17549.74', 'spread': '27854', 'groupId': 'OG002'}, {'value': '15375.10', 'spread': '16999', 'groupId': 'OG003'}, {'value': '18110.14', 'spread': '26365', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.516', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '932.88', 'ciLowerLimit': '-1880.17', 'ciUpperLimit': '3745.94', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4902.02', 'ciLowerLimit': '767.60', 'ciUpperLimit': '9036.43', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2727.38', 'ciLowerLimit': '323.48', 'ciUpperLimit': '5131.27', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.000', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5462.41', 'ciLowerLimit': '2520.93', 'ciUpperLimit': '8403.90', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.', 'description': 'Total all-cause medical costs per patient calculated as the sum of the total amounts paid for all medical services by the payer and the patient. The types of medical services covered by Medicare included inpatient facility, outpatient facility, skilled nursing facility, home health care, hospice, durable medical equipment, clinician office visits, and other physician services covered under the Part B benefit. The costs with prescriptions covered under Part D benefit were excluded from this outcome analysis.', 'unitOfMeasure': 'United States dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Total IPF-related Medical Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '781', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '255', 'groupId': 'OG003'}, {'value': '370', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'High Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'OG001', 'title': 'Moderate Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'OG002', 'title': 'High-then-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline.'}, {'id': 'OG003', 'title': 'Delayed-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline.'}, {'id': 'OG004', 'title': 'Early-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline.'}], 'classes': [{'categories': [{'measurements': [{'value': '3239.75', 'spread': '6313', 'groupId': 'OG000'}, {'value': '2935.82', 'spread': '4574', 'groupId': 'OG001'}, {'value': '6011.81', 'spread': '16239', 'groupId': 'OG002'}, {'value': '3696.54', 'spread': '6525', 'groupId': 'OG003'}, {'value': '3860.62', 'spread': '12947', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.439', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-303.94', 'ciLowerLimit': '-1074.77', 'ciUpperLimit': '466.90', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2772.06', 'ciLowerLimit': '422.10', 'ciUpperLimit': '5122.02', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.328', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '456.79', 'ciLowerLimit': '-458.64', 'ciUpperLimit': '1372.21', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.382', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '620.87', 'ciLowerLimit': '-771.77', 'ciUpperLimit': '2013.51', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.', 'description': 'The total Idiopathic Pulmonary Fibrosis (IPF) related medical costs per patient were calculated as the sum of the total amounts paid by the payers and the patients for all medical services for an IPF-related reason containing at least one IPF diagnosis code.', 'unitOfMeasure': 'United States dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'All-cause Inpatient Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '781', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '255', 'groupId': 'OG003'}, {'value': '370', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'High Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'OG001', 'title': 'Moderate Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'OG002', 'title': 'High-then-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline.'}, {'id': 'OG003', 'title': 'Delayed-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline.'}, {'id': 'OG004', 'title': 'Early-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}, {'value': '29.4', 'groupId': 'OG003'}, {'value': '26.8', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.463', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '8.9', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.6', 'ciLowerLimit': '2.5', 'ciUpperLimit': '16.8', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.1', 'ciLowerLimit': '2.8', 'ciUpperLimit': '15.3', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '1.1', 'ciUpperLimit': '11.7', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.', 'description': 'Percentage of patients with at least one inpatient hospitalization for any cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'IPF-related Inpatient Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '781', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '255', 'groupId': 'OG003'}, {'value': '370', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'High Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'OG001', 'title': 'Moderate Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'OG002', 'title': 'High-then-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline.'}, {'id': 'OG003', 'title': 'Delayed-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline.'}, {'id': 'OG004', 'title': 'Early-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}, {'value': '19.5', 'groupId': 'OG002'}, {'value': '14.1', 'groupId': 'OG003'}, {'value': '12.2', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.801', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '5.5', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.7', 'ciLowerLimit': '2.7', 'ciUpperLimit': '14.8', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.170', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '8.2', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.489', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '5.4', 'estimateComment': 'The net difference was calculated as:\n\nComparator - Reference\n\nwhere High nintedanib adherence group was used as reference.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.', 'description': 'Percentage of patients with at least one inpatient hospitalization for any Idiopathic Pulmonary Fibrosis (IPF)-related cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'FG001', 'title': 'Moderate Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'FG002', 'title': 'High-then-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline.'}, {'id': 'FG003', 'title': 'Delayed-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline.'}, {'id': 'FG004', 'title': 'Early-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '781'}, {'groupId': 'FG001', 'numSubjects': '202'}, {'groupId': 'FG002', 'numSubjects': '190'}, {'groupId': 'FG003', 'numSubjects': '255'}, {'groupId': 'FG004', 'numSubjects': '370'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '781'}, {'groupId': 'FG001', 'numSubjects': '202'}, {'groupId': 'FG002', 'numSubjects': '190'}, {'groupId': 'FG003', 'numSubjects': '255'}, {'groupId': 'FG004', 'numSubjects': '370'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Retrospective cohort study using United States (US) Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) administrative claims to characterize the trajectory of adherence to nintedanib in Idiopathic Pulmonary Fibrosis (IPF) patients as measured during the first year following initiation. The study uses data covering the period of 01-Oct-2013 to 31-12-2020, capturing the first use of nintedanib (index date) between 01-Oct-2014 and 31-Oct-2018.', 'preAssignmentDetails': 'Patients that met all inclusion criteria and none of the exclusion criteria were followed 12 months before the first use of nintedanib (baseline period) to 24 months after its initiation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '781', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}, {'value': '370', 'groupId': 'BG004'}, {'value': '1798', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'High Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'BG001', 'title': 'Moderate Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.'}, {'id': 'BG002', 'title': 'High-then-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline.'}, {'id': 'BG003', 'title': 'Delayed-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline.'}, {'id': 'BG004', 'title': 'Early-poor Nintedanib Adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.65', 'spread': '5.36', 'groupId': 'BG000'}, {'value': '75.21', 'spread': '5.45', 'groupId': 'BG001'}, {'value': '75.89', 'spread': '5.60', 'groupId': 'BG002'}, {'value': '76.29', 'spread': '5.61', 'groupId': 'BG003'}, {'value': '76.21', 'spread': '5.62', 'groupId': 'BG004'}, {'value': '75.40', 'spread': '5.53', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '177', 'groupId': 'BG004'}, {'value': '700', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '530', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}, {'value': '193', 'groupId': 'BG004'}, {'value': '1098', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Non-hispanic white', 'measurements': [{'value': '718', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}, {'value': '237', 'groupId': 'BG003'}, {'value': '329', 'groupId': 'BG004'}, {'value': '1638', 'groupId': 'BG005'}]}, {'title': 'Not non-hispanic white', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '160', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-09', 'size': 819931, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-11T07:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1798}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2023-05-15', 'resultsFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-20', 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total All-cause Medical Costs', 'timeFrame': 'At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.', 'description': 'Total all-cause medical costs per patient calculated as the sum of the total amounts paid for all medical services by the payer and the patient. The types of medical services covered by Medicare included inpatient facility, outpatient facility, skilled nursing facility, home health care, hospice, durable medical equipment, clinician office visits, and other physician services covered under the Part B benefit. The costs with prescriptions covered under Part D benefit were excluded from this outcome analysis.'}], 'secondaryOutcomes': [{'measure': 'Total IPF-related Medical Costs', 'timeFrame': 'At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.', 'description': 'The total Idiopathic Pulmonary Fibrosis (IPF) related medical costs per patient were calculated as the sum of the total amounts paid by the payers and the patients for all medical services for an IPF-related reason containing at least one IPF diagnosis code.'}, {'measure': 'All-cause Inpatient Hospitalization', 'timeFrame': 'At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.', 'description': 'Percentage of patients with at least one inpatient hospitalization for any cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place.'}, {'measure': 'IPF-related Inpatient Hospitalization', 'timeFrame': 'At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.', 'description': 'Percentage of patients with at least one inpatient hospitalization for any Idiopathic Pulmonary Fibrosis (IPF)-related cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This study has two objectives:\n\n1. To assess the association between nintedanib adherence trajectory group (as measured from a Group-based Trajectory Modelling (GBTM)) and health care resource use, with a focus on inpatient hospitalization, among patients with Idiopathic Pulmonary Fibrosis (IPF).\n2. To assess the association between a patient's nintedanib adherence trajectory group (as measured from a GBTM) and their medical costs among patients with IPF."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '66 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IPF patients in United States which were newly initiated on nintedanib during 10-Jan-2014 to 31-Dec-2018.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly initiated nintedanib during 10/01/2014 to 12/31/2018\n* Were at least 66 years old as of the date of their first nintedanib prescription claim (index date)\n* Qualified for Medicare based on age\n* Had at least 12 months of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months after the index date (follow-up period)\n* Had at least one inpatient or two outpatient claims (\\>14 days apart) with a diagnosis code for IPF (ICD-10-CM: J84.112; ICD-9-CM: 516.31) during the baseline period\n\nExclusion Criteria:\n\n* Had any history of pirfenidone or nintedanib use during the baseline period\n* Had any history of lung transplant during the baseline, index date or follow-up periods\n* Had any claims for skilled nursing facility, long-term care facility or hospice during the baseline, index date or follow-up period\n* Had evidence (≥2 ICD-9-CM or ICD-10-CM diagnosis codes on different dates) during the baseline period of any of the following conditions: lung cancer, autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's, and mixed connective tissue disease (CTD)) during the baseline period\n* Had dual eligibility of Medicare and Medicaid\n* Had history of using pirfenidone at the same time with nintedanib during follow-up"}, 'identificationModule': {'nctId': 'NCT05870956', 'briefTitle': 'Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Economic Burden Associated With Nintedanib Non-adherence Among Medicare Beneficiaries With IPF', 'orgStudyIdInfo': {'id': '1199-0520'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High nintedanib adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.', 'interventionNames': ['Drug: Nintedanib']}, {'label': 'Moderate nintedanib adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation.', 'interventionNames': ['Drug: Nintedanib']}, {'label': 'High-then-poor nintedanib adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline.', 'interventionNames': ['Drug: Nintedanib']}, {'label': 'Delayed-poor nintedanib adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline.', 'interventionNames': ['Drug: Nintedanib']}, {'label': 'Early-poor nintedanib adherence', 'description': 'Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline.', 'interventionNames': ['Drug: Nintedanib']}], 'interventions': [{'name': 'Nintedanib', 'type': 'DRUG', 'otherNames': ['Ofev®'], 'description': 'Nintedanib', 'armGroupLabels': ['Delayed-poor nintedanib adherence', 'Early-poor nintedanib adherence', 'High nintedanib adherence', 'High-then-poor nintedanib adherence', 'Moderate nintedanib adherence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02186', 'city': 'Milton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Medicus Economics, LCC', 'geoPoint': {'lat': 42.24954, 'lon': -71.06616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to:\n\nhttps://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}