Ipilimumab 12-month Intensive Pharmacovigilance Protocol

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02050594
• Date of registration: 14/01/2014
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Ipilimumab 12-month Intensive Pharmacovigilance Protocol
• Scientific title: Ipilimumab 12-month Intensive Pharmacovigilance Protocol
• Date of first enrolment: February 2014
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02050594
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Venezuela

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Melanoma

Intervention(s)

Drug: Ipilimumab

Primary Outcome(s)

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]

Secondary ID(s)

CA184-366

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

JSS Medical Research Inc.