Interferon Toxicities in Melanoma Treatment

Stage III Melanoma Clinical Trial

— ITMT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794636
• Other study ID #: CA184-404
• Status: Completed
• Phase: N/A
• First received: June 6, 2016
• Last updated: June 6, 2016
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Melanoma
• Stage III Melanoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy		180 days prior to the index date	Yes
Primary	Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy		180 days after the index date	Yes
Primary	Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy		180 days prior to the index date	Yes
Primary	Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy		180 days after the index date	Yes
Primary	Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy		180 days prior to the index date	Yes
Primary	Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy		180 days after the index date	Yes
Secondary	Pre-IFN treatment period Health care costs related to depression		180 days prior to the index date	No
Secondary	Post-IFN treatment period Health care costs related to depression		180 days after the index date	No
Secondary	Pre-IFN treatment period Health care costs related to fatigue		180 days prior to the index date	No
Secondary	Post-IFN treatment period Health care costs related to fatigue		180 days after the index date	No
Secondary	Pre-IFN treatment period Health care costs related to myalgia		180 days prior to the index date	No
Secondary	Post-IFN treatment period Health care costs related to myalgia		180 days after the index date	No

External Links

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