nctId: NCT06369428 id: CDRB436BFI02 briefTitle: Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients overallStatus: COMPLETED date: 2021-06-23 date: 2023-04-13 date: 2023-04-13 date: 2024-04-17 date: 2024-04-17 name: Novartis class: INDUSTRY 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. conditions: Metastatic Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1795 type: ACTUAL measure: Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021 measure: Point Prevalence per 100,000 Population measure: Mean Age of Patients at Index Date per Hospital District measure: Mean Length of Follow-up at Index Date per Hospital District measure: Gender at Index Date per Hospital District measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District measure: Number of Patients with Negative BRAF Status at Index Date per Hospital District measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District measure: Number of Patients by Number of Metastatic Organs at Index Date per Hospital District measure: Number of Patients by Location of Metastases at Index Date per Hospital District measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District measure: Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication measure: Overall Survival (OS) measure: Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment measure: Duration of Treatment (DoT) measure: Mean Age at Index Date per First-line (1L) Medication measure: Length of Follow-up at Index Date per 1L Medication measure: Time to Treatment at Index Date per 1L Medication measure: Gender at Index Date per 1L Medication measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication measure: Number of Patients with Negative BRAF Status at Index Date per 1L Medication measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication measure: Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication measure: Number of Patients by Location of Metastases at Index Date per 1L Medication measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication measure: Number of Patients that Received Radiotherapy During 1L Treatment measure: Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment measure: Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment measure: Number of Patients Switched from TT 1L Treatment to IO 2L Treatment measure: Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment measure: Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment measure: Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment measure: Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment measure: Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment measure: Number of Patients Switched from TT 2L Treatment to IO 3L Treatment measure: Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment measure: Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment measure: Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment measure: Number of Healthcare Contacts and Associated Costs per Patient Year measure: Number of Healthcare Contacts and Associated Costs per Patient measure: Number of Healthcare Contacts and Associated Total Costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis city: Basel zip: 4056 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False