Ipilimumab 12-month Intensive Pharmacovigilance Protocol

Completed

• Conditions: Melanoma
• Interventions: Drug: Ipilimumab

• Registration Number: NCT02050594
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Study Start: 2014-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-03
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Melanoma patients on Ipilimumab	Ipilimumab	All unresectable, recurrent or metastatic melanoma patients

Primary Outcome Measures

Name	Time	Method
Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela	Up to 12 months of treatment

Trial Locations

Locations (1)

Local Institution; 🇻🇪 Caracas, Venezuela