Ipilimumab 12-month Intensive Pharmacovigilance Protocol

N/ACompletedNCT02050594

Bristol-Myers Squibb6 enrolled

Overview

The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma

Interventions

IpilimumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Age of 18 years or older on date of first dose of Ipilimumab * Subjects who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in Venezuela Exclusion Criteria: * Subjects who received Ipilimumab as part of a clinical trial * Subjects who received Ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma)

Locations (1)

Local Institution

Caracas, Venezuela

Outcomes

Primary Outcomes

Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela

Time frame: Up to 12 months of treatment

Data from ClinicalTrials.gov

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