Interferon Toxicities in Melanoma Treatment (ITMT)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Stage III Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT02794636

CA184-404

Details and patient eligibility

About

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.

Enrollment: 436 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

436 participants in 1 patient group

IFN Treatment

Description:

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