The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting
Time Perspective: this study does have a retrospective component involving a subset of patients
Study Type
OBSERVATIONAL
Enrollment
1,411
Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting
Time frame: Every 12 months up to 5 years
Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events
Time frame: Every 12 months up to 5 years
Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
Time frame: Every 12 months up to 5 years
Patterns of disease monitoring as observed in a real-world setting
To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination
Time frame: Every 12 months up to 5 years
Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma
Time frame: Every 12 months up to 5 years
Resource utilization associated with advanced melanoma treatment
Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs
Time frame: Every 12 months up to 5 years
Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma
Time frame: Every 12 months up to 5 years
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