Ipilimumab 12-month Intensive Pharmacovigilance Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Melanoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Melanoma patients on Ipilimumab

All unresectable, recurrent or metastatic melanoma patients

Ipilimumab

Intervention Type DRUG

Interventions

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Ipilimumab

Intervention Type DRUG

Other Intervention Names

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Yervoy

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No