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This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy [IO], or targeted therapy [TT] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy (IO) | Patients receiving IO |
| |
| Targeted therapy (TT) | Patients receiving TT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Patients receiving nivolumab |
| |
| Ipilimumab + nivolumab |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients on first systemic adjuvant therapy with adverse avents (AEs) | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation. | Up to approximately 5 years | |
| Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy | Up to approximately 5 years |
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Inclusion Criteria
Exclusion Criteria
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This was a retrospective, noninterventional cohort study
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States |
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| Drug |
Patients receiving ipilimumab + nivolumab |
|
| Pembrolizumab | Drug | Patients receiving pembrolizumab |
|
| Dabrafenib + trametinib | Drug | Dabrafenib + trametinib |
|
| Healthcare costs associated with AEs on first systemic adjuvant therapy | Up to approximately 5 years |
| HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation | Up to approximately 5 years |
| Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation | Up to approximately 5 years |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| 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 |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| C582435 | pembrolizumab |
| C561627 | dabrafenib |
| C560077 | trametinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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