Interferon Toxicities in Melanoma Treatment

Completed

• Conditions: Stage III Melanoma

• Registration Number: NCT02794636
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-06
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-06
• Last Update Submitted: 2016-06-06
• Study First Posted: 2016-06-09
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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