Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma

Bristol-Myers Squibb556 enrolled

Overview

This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice

Study Type

OBSERVATIONAL

Enrollment

556

Conditions

Melanoma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All patients who are initiating treatment with Yervoy Exclusion Criteria: * Not Applicable Other protocol defined inclusion/exclusion criteria could apply

Locations (2)

Local Institution

Chiyoda-ku, Tokyo, Japan

Local Institution

Tokyo, Japan

Outcomes

Primary Outcomes

The incidence of adverse events (AEs) by types among the analysis population

Time frame: 12 months

The Overall Survival (OS) Rate

Time frame: 12 months

The factors that potentially affect safety or effectiveness

Stratified analysis on the incidence of adverse events (AEs) and effectiveness by patient background

Time frame: 12 months

Data from ClinicalTrials.gov

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