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Completed

NCT Number: NCT03165409

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bristol-Myers Squibb

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Melanoma intervention

Other names: BMS-936558, Opdivo

Ipilimumab

Biological

Melanoma intervention

Other names: BMS-734016, Yervoy

Primary outcomes

  1. 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

    Time frame: Approximately 5 years

  2. 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

    Time frame: Approximately 5 years

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

    Time frame: Approximately 5 years

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

    Time frame: Approximately 5 years

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

    Time frame: Approximately 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 24, 2017
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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