Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07151820
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Real-world Study About the Impact of Adverse Events (AEs) on Treatment Adjustments, Healthcare Resource Use, and Costs Among Chronic Myeloid Leukemia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2546}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With AEs of Interest During the Study Period Among Those Without the Specific Event During the Baseline Period', 'timeFrame': 'Up to approximately 7 years and 3 months', 'description': 'The Study Period spanned from treatment initiation until treatment discontinuation, one day before treatment switch to another CML treatment, end of data availability, end of health plan coverage, or death, whichever came first.'}, {'measure': 'Number of Patients With AEs of Interest Among All Patients During the Study Period', 'timeFrame': 'Up to approximately 7 years and 3 months', 'description': 'The Study Period spanned from treatment initiation until treatment discontinuation, one day before treatment switch to another CML treatment, end of data availability, end of health plan coverage, or death, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Treatment Adjustments During the Observation Period', 'timeFrame': 'Up to approximately 7 years and 3 months', 'description': 'The Observation Period spanned from treatment initiation to the end of data availability, end of health plan coverage, or death, whichever occurred first.\n\nTreatment adjustments included:\n\n* Treatment discontinuation\n* Treatment interruption\n* Switching treatment\n* Dose reduction'}, {'measure': 'Duration of First Treatment Interruption', 'timeFrame': 'Up to approximately 7 years and 3 months'}, {'measure': 'Time From TKI Initiation to Treatment Adjustment', 'timeFrame': 'Up to approximately 7 years and 3 months', 'description': 'Treatment adjustments included:\n\n* Treatment discontinuation\n* Treatment interruption\n* Switching treatment\n* Dose reduction'}, {'measure': 'Number of Patients With AEs of Interest Within 30 Days Before Treatment Adjustment', 'timeFrame': '6 months', 'description': 'Treatment adjustments included:\n\n* Treatment discontinuation\n* Treatment interruption\n* Dose reduction'}, {'measure': 'Number of AEs of Interest Within 30 Days Before Treatment Adjustment', 'timeFrame': '6 months', 'description': 'Treatment adjustments included:\n\n* Treatment discontinuation\n* Treatment interruption\n* Dose reduction'}, {'measure': 'Number of Patients by AE of Interest Experienced Within 30 Days Before Treatment Adjustment', 'timeFrame': '6 months', 'description': 'Treatment adjustments included:\n\n* Treatment discontinuation\n* Treatment interruption\n* Dose reduction'}, {'measure': 'Time Between the Last AE of Interest and Treatment Adjustment', 'timeFrame': '6 months', 'description': 'Treatment adjustments included:\n\n* Treatment discontinuation\n* Treatment interruption\n* Dose reduction'}, {'measure': 'Number of Patients by Last AE of Interest Experienced Before Treatment Adjustment', 'timeFrame': '6 months', 'description': 'Treatment adjustments included:\n\n* Treatment discontinuation\n* Treatment interruption\n* Dose reduction'}, {'measure': 'Number of All-cause Healthcare Visits Per-Patient-Per-Year (PPPY)', 'timeFrame': '6 months', 'description': 'Healthcare visits included:\n\n* Inpatient admissions\n* Emergency department visits\n* Outpatient visits\n* Other visits'}, {'measure': 'Number of Patients With One or More All-cause Healthcare Visits', 'timeFrame': '6 months', 'description': 'Healthcare visits included:\n\n* Inpatient admissions\n* Emergency department visits\n* Outpatient admissions\n* Other visits'}, {'measure': 'Number of All-cause Inpatient Days', 'timeFrame': '6 months'}, {'measure': 'Number of All-cause Inpatient Days Among Hospitalized Patients', 'timeFrame': '6 months'}, {'measure': 'All-cause Healthcare Costs PPPY', 'timeFrame': '6 months', 'description': 'Healthcare costs included:\n\n* Total costs\n* Medical costs\n* Inpatient costs\n* Emergency department costs\n* Outpatient costs\n* Other costs\n* Pharmacy costs'}, {'measure': 'Annual Mean Number of Healthcare Visits Associated With AEs of Interest', 'timeFrame': '6 months', 'description': 'Healthcare visits included:\n\n* Inpatient admissions\n* Emergency department visits\n* Outpatient admissions\n* Other visits'}, {'measure': 'Annual Mean Costs of Healthcare Visits Associated With AEs of Interest', 'timeFrame': '6 months', 'description': 'Healthcare costs included:\n\n* Total costs\n* Medical costs\n* Inpatient costs\n* Emergency department costs\n* Outpatient costs\n* Other costs\n* Pharmacy costs'}]}, 'conditionsModule': {'keywords': ['Tyrosine kinase inhibitor', 'Adverse events', 'Treatment adjustment', 'Healthcare resource use', 'Healthcare costs'], 'conditions': ['Leukemia, Chronic Myeloid']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess the frequency of adverse events (AEs) experienced by chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) and evaluate their impact on treatment adjustments as well as the burden of AEs on healthcare resource use (HRU) and costs.\n\nThis study used real-world administrative claims data from the PharMetrics Plus database. AEs of interest were selected based on information obtained from the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, Chronic Myeloid Leukemia Version 1. 2024 and clinical inputs. Given the nature of claims data, only AEs of interest that required medical attention (i.e., resulted in a claim record) were captured in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatients who met all of the following criteria were considered for inclusion:\n\n* Had at least two diagnoses for CML- International Classification of Disease, 10th revision, Clinical Modification (ICD-10-CM) code: C92.1x\n* Aged 18 years or older at the time of first CML diagnosis\n* Received a 1G or 2G TKI after the first CML diagnosis\n* Had continuous health plan enrollment (pharmacy and medical benefits) for at least 6 months before the index date (baseline) and 6 months after the index date\n\nExclusion criteria:\n\nPatients who met any of the following criteria were excluded:\n\n* Patients had 2 or more diagnoses of gastrointestinal stromal tumor (\\[GIST\\], ICD-10: C49.Ax) or chronic myelomonocytic leukemia (\\[CMML\\], ICD-10: C93.1x) at any time\n* Patients had a hematopoietic stem cell transplantation (HSCT) during the baseline period\n* Patients had CML-related chemotherapy treatment for accelerated phase (AP)/blast crisis (BC) during the baseline period\n* Patients had medical claims associated with a clinical trial during the baseline period up to the end of the observation period'}, 'identificationModule': {'nctId': 'NCT07151820', 'briefTitle': 'A Real-world Study About the Impact of Adverse Events (AEs) on Treatment Adjustments, Healthcare Resource Use, and Costs Among Chronic Myeloid Leukemia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Association of Adverse Events in the Real World With Treatment Adjustments, and Burden of AEs in Patients With Chronic Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'CABL001A0US08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First Generation (1G) TKI Cohort', 'description': 'Adult CML patients who received imatinib, a 1G TKI.'}, {'label': 'Second Generation (2G) TKI Cohort', 'description': 'Adult CML patients who received the following 2G TKIs: dasatinib, nilotinib, or bosutinib.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}