Ipilimumab 12-month Intensive Pharmacovigilance Protocol

Sponsor
Bristol-Myers Squibb
Study ID
NCT02050594
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Feb 28, 2014
Status verified
Jul 2015
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

Enrollment
6 participants (actual)

Arms

  • Arm: Melanoma patients on Ipilimumab
    All unresectable, recurrent or metastatic melanoma patients

Primary Outcome Measure

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 ]

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