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

NCT03165409 | Completed

• 1 other identifier: CA209-789
• Study Type: observational
• Target: 1,828
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Treatment-related and all-cause AE costs for nivolumab/ipilimumab combination therapy for metastatic melanoma

  Approximately 5 years

• Treatment-related and all-cause AE costs for nivolumab monotherapy for metastatic melanoma

  Approximately 5 years

• Treatment-related and all-cause AE costs for ipilimumab monotherapy for metastatic melanoma

  Approximately 5 years

Interventions

Nivolumab BIOLOGICAL

Melanoma intervention

Also known as: BMS-936558, Opdivo

Ipilimumab BIOLOGICAL

Melanoma intervention

Also known as: BMS-734016, Yervoy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who were diagnosed with metastatic melanoma and initiated at least 1 treatment for metastatic melanoma after 2011 will be identified from the IMS PharMetrics Plus US Claims Database and included in the study sample. Patients must have had continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date. The population from the CheckMate-067 (CA209-067) clinical trial will also be included. The population consists of all patients who received at least 1 dose of study drug.

You may qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bristol-Myers Squibb

Princeton, New Jersey, 08540, United States

Location

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 24, 2017
• Study Start: February 27, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

US (1)