Analysis of the Clinical and Economic Impact of Adverse Events and Medication-related Toxicities Associated With Interferon (IFN) Treatment for Patients With Stage III Melanoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 436
- Primary Endpoint
- Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a pharmacy claim for IFN between 1/1/2007 and 12/31/
- •The date of the first observed claim will be defined as the index date
- •Patients with a melanoma diagnosis based on two medical claims prior to the index date
- •Patients with a procedure code for melanoma-related lymph node dissection before the index date
- •Patients ≥ 18 years of age on or before the index date
- •Patients with continuous benefit enrollment for at least 180 days before and after the index date
Exclusion Criteria
- •Patients with diagnosis of any other (primary) cancer during the 180-day pre-index period (excepting skin cancers and hematologic malignancies)
- •Patients with diagnosis of a secondary cancer during the 180-day pre-index period or on the index date (excepting lymph node metastasis to a site common for melanoma or an improbable site for any other primary cancer)
- •Patients who received systemic chemotherapy during the pre- or post-index period
Outcomes
Primary Outcomes
Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy
Time Frame: 180 days prior to the index date
Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy
Time Frame: 180 days after the index date
Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy
Time Frame: 180 days prior to the index date
Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy
Time Frame: 180 days after the index date
Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy
Time Frame: 180 days prior to the index date
Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy
Time Frame: 180 days after the index date
Secondary Outcomes
- 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)
- 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)