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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03165409

Enrollment

1828

Registered

2017-05-24

Start date

2017-02-27

Completion date

2017-09-30

Last updated

2017-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

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.

Interventions

BIOLOGICALNivolumab

Melanoma intervention

BIOLOGICALIpilimumab

Melanoma intervention

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026