Non-interventional Register-based Study to Analyze Patient Characteristics, Treatment Patterns and Healthcare Resource Utilization in Adult Patients With Metastatic Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,795
- 试验地点
- 1
- 主要终点
- Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021
时间窗: Up to approximately 7 years
Gender at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Point Prevalence per 100,000 Population
时间窗: Up to approximately 7 years
Point prevalence was defined as the number of metastatic melanoma patients alive at the end of 2021 divided by the total of hospital districts of Helsinki and Uusimaa hospital district (HUS), Pirkanmaa hospital district (PSHP), and Hospital district of Southwest Finland (VSSHP).
Mean Age of Patients at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Mean Length of Follow-up at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (≥2).
Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Number of Patients with Negative BRAF Status at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Number of Patients by Location of Metastases at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Locations of metastatic sites at study entry: * lymph node * lung * skin/subcutaneous * liver * brain * bone * kidney * peritoneum/peritoneal cavity * spleen * pancreas * intestine
Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication
时间窗: 5 years prior to index date, where index date was defined as date of metastasis diagnosis
Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Number of Patients by Number of Metastatic Organs at Index Date per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District
时间窗: Index date, defined as date of metastasis diagnosis
次要结局
- Time to Treatment at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Overall Survival (OS)(Up to approximately 7 years)
- Duration of Treatment (DoT)(Up to approximately 7 years)
- Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment(Up to approximately 7 years)
- Length of Follow-up at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Mean Age at Index Date per First-line (1L) Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients with Negative BRAF Status at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment(Up to approximately 7 years)
- Number of Patients Switched from TT 1L Treatment to IO 2L Treatment(Up to approximately 7 years)
- Number of Patients Switched from TT 2L Treatment to IO 3L Treatment(Up to approximately 7 years)
- Gender at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment(Up to approximately 7 years)
- Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment(Up to approximately 7 years)
- Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment(Up to approximately 7 years)
- Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment(Up to approximately 7 years)
- Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment(Up to approximately 7 years)
- Number of Healthcare Contacts and Associated Costs per Patient Year(Up to approximately 7 years)
- Number of Patients by Location of Metastases at Index Date per 1L Medication(Index date, defined as date of metastasis diagnosis)
- Number of Patients that Received Radiotherapy During 1L Treatment(Index date, defined as date of metastasis diagnosis)
- Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment(Up to approximately 7 years)
- Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment(Up to approximately 7 years)
- Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment(Up to approximately 7 years)
- Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment(Up to approximately 7 years)
- Number of Healthcare Contacts and Associated Costs per Patient(Up to approximately 7 years)
- Number of Healthcare Contacts and Associated Total Costs(Up to approximately 7 years)