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NCT03165409 Clinical Trial

Cost of Adverse Events Related to How Often Follow-Up Occurs Among Patients With Cancer That Has Spread

Melanoma Clinical Trial

Official title:
Economic Burden of Adverse Events Associated With Follow-Up Frequency Among Patients With Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03165409
Other study ID # CA209-789
Secondary ID
Status Completed
Phase N/A
First received May 23, 2017
Last updated October 4, 2017
Start date February 27, 2017
Est. completion date September 30, 2017

Study information
Verified date October 2017
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a real-world retrospective claims analysis to assess and compare AE-related HCRU and medical costs among patients with different follow-up frequency after initiating a melanoma therapy.

Recruitment information / eligibility
Status Completed
Enrollment 1828
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with metastatic melanoma

- Initiated at least 1 treatment for metastatic melanoma after 2011

- Continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date

- Patients who received at least 1 dose of study drug in CA209-067

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Nivolumab
Melanoma intervention
• Ipilimumab
Melanoma intervention

Locations
Country Name City State
United States Bristol-Myers Squibb Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with less frequent general outpatient visits Approximately 5 years
Primary Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with more frequent general outpatient visits Approximately 5 years
Primary Treatment-related and all-cause AE costs for nivolumab/ipilimumab combination therapy for metastatic melanoma Approximately 5 years
Primary Treatment-related and all-cause AE costs for nivolumab monotherapy for metastatic melanoma Approximately 5 years
Primary Treatment-related and all-cause AE costs for ipilimumab monotherapy for metastatic melanoma Approximately 5 years
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