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The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and resource utilization before and after IFN initiation among patients with stage III melanoma in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFN Treatment | Adult (age ≥ 18 years) patients identified as having stage III melanoma and no other primary or secondary cancer who initiated treatment with IFN between 1/1/2007 and 12/31/2011. Patients are required to have continuous pharmaceutical benefit enrollment for 180 days before (pre-index) and after (post-index) IFN initiation and no evidence of treatment with systemic chemotherapy during the pre- or post-index period |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy | 180 days prior to the index date | |
| Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy | 180 days after the index date | |
| Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy | 180 days prior to the index date | |
| Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy | 180 days after the index date | |
| Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy | 180 days prior to the index date | |
| Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy | 180 days after the index date |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-IFN treatment period Health care costs related to depression | 180 days prior to the index date | |
| Post-IFN treatment period Health care costs related to depression | 180 days after the index date |
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Inclusion Criteria:
Exclusion Criteria:
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Health plan enrollees whose data are reflected in the Truven Health MarketScan Commercial and Medicare Supplemental database. This database captures clinical utilization, expenditures and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Pre-IFN treatment period Health care costs related to fatigue | 180 days prior to the index date |
| Post-IFN treatment period Health care costs related to fatigue | 180 days after the index date |
| Pre-IFN treatment period Health care costs related to myalgia | 180 days prior to the index date |
| Post-IFN treatment period Health care costs related to myalgia | 180 days after the index date |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |