protocolSection identificationModule nctId: NCT06369428, orgStudyIdInfo id: CDRB436BFI02, briefTitle: Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-23, primaryCompletionDateStruct date: 2023-04-13, completionDateStruct date: 2023-04-13, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Novartis, class: INDUSTRY, descriptionModule briefSummary: This was a retrospective, non-interventional, registry study based on secondary electronic medical record (EMR) data collected in Helsinki and Uusimaa hospital district (HUS data lake), hospital district of Southwest Finland (VSSHP data lake) and Pirkanmaa hospital district (PSHP data lake) as a part of their routine clinical practice. Social Insurance Institution of Finland (SII; reimbursed drug purchases) was utilized in this study to complement the medication data. The metastatic melanoma patients were stratified by first-line treatment and by hospital district., conditionsModule conditions: Metastatic Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1795, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021, primaryOutcomes measure: Point Prevalence per 100,000 Population, primaryOutcomes measure: Mean Age of Patients at Index Date per Hospital District, primaryOutcomes measure: Mean Length of Follow-up at Index Date per Hospital District, primaryOutcomes measure: Gender at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District, primaryOutcomes measure: Number of Patients with Negative BRAF Status at Index Date per Hospital District, primaryOutcomes measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District, primaryOutcomes measure: Number of Patients by Number of Metastatic Organs at Index Date per Hospital District, primaryOutcomes measure: Number of Patients by Location of Metastases at Index Date per Hospital District, primaryOutcomes measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District, primaryOutcomes measure: Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment, secondaryOutcomes measure: Duration of Treatment (DoT), secondaryOutcomes measure: Mean Age at Index Date per First-line (1L) Medication, secondaryOutcomes measure: Length of Follow-up at Index Date per 1L Medication, secondaryOutcomes measure: Time to Treatment at Index Date per 1L Medication, secondaryOutcomes measure: Gender at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients with Negative BRAF Status at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients by Location of Metastases at Index Date per 1L Medication, secondaryOutcomes measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication, secondaryOutcomes measure: Number of Patients that Received Radiotherapy During 1L Treatment, secondaryOutcomes measure: Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment, secondaryOutcomes measure: Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from TT 1L Treatment to IO 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment, secondaryOutcomes measure: Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment, secondaryOutcomes measure: Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment, secondaryOutcomes measure: Number of Patients Switched from TT 2L Treatment to IO 3L Treatment, secondaryOutcomes measure: Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment, secondaryOutcomes measure: Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment, secondaryOutcomes measure: Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment, secondaryOutcomes measure: Number of Healthcare Contacts and Associated Costs per Patient Year, secondaryOutcomes measure: Number of Healthcare Contacts and Associated Costs per Patient, secondaryOutcomes measure: Number of Healthcare Contacts and Associated Total Costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis, city: Basel, zip: 4056, country: Switzerland, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False