NCT02050594CompletedNot Applicable
Ipilimumab 12-month Intensive Pharmacovigilance Protocol
Bristol-Myers Squibb1 site in 1 country6 target enrollmentStarted: February 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Melanoma patients on Ipilimumab
All unresectable, recurrent or metastatic melanoma patients
Intervention: Ipilimumab (Drug)
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Terminated
Not Applicable
Dupilumab Phase 4 StudyAtopic DermatitisNCT03411837Northwestern University46
Completed
Not Applicable
Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)Pulmonary HypertensionNCT00666198Pfizer's Upjohn has merged with Mylan to form Viatris Inc.3,337
Completed
Not Applicable
Special Drug Use Investigation for PAXIL Tablet (Long-term)Mental DisordersNCT01371448GlaxoSmithKline339
Completed
Not Applicable
PAN-EU Utilization, Effectiveness and Safety of Ipilimumab Administered in EAP Patients With Advanced MelanomaMelanomaNCT02492815Bristol-Myers Squibb1,773
Completed
Not Applicable
Safety And Efficacy Of Rifabutin In HIV PatientsNon-tuberculous Mycobacterial DiseasesInhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV InfectionsTuberculosisNCT00810446Pfizer72