Interferon Toxicities in Melanoma Treatment

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.

Official Title
-----------------
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

Conditions
-----------------
Stage III Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a pharmacy claim for IFN between 1/1/2007 and 12/31/2011. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IFN Treatment<br>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 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |