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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Melanoma intervention |
| |
| Ipilimumab | Biological | Melanoma intervention |
|
| Measure | Description | 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 |
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Inclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol-Myers Squibb | Princeton | New Jersey | 08540 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |