Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Malignant melanoma
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

426188
Study design details

Main study objective

1. Describe the demographic and clinical characteristics of patients diagnosed with malignant melanoma 2. Describe one-year overall and net survival over time among malignant melanoma patients, and among subgroups of interest (disease stage and socioeconomic status)3. Model changes in survival over time among these patients4. Assess changes in survival within subgroups of interest

Outcomes

The primary outcomes of interest in this study are overall survival and relative survival. These will be assessed from the day after index until the last day of available data (during follow-up).

Data analysis plan

The demographic and clinical characteristics of the overall malignant melanoma cohort will be summarized using descriptive statistics. The non-parametric KM method will be used to estimate one-year OS for the overall study cohort and within each subgroup of interest, stratified by calendar year of diagnosis. Relative survival will be calculated as the ratio of overall survival for malignant melanoma patients during the one-year period following index date to the overall survival among a comparable cancer free population over the same one-year period. Trends in OS will be modeled using multivariable Cox proportional hazards models.Trends in relative survival will be modeled using generalized linear models using a Poisson assumption for the observed number of death.