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The research questions to be addressed by this study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort Population | Individuals included in a large US-based administrative medical claims database with underlying autoimmune disorder exposed to ipilimumab for the treatment of melanoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Biological | Intravenous monoclonal antibody injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition | Approximately 40 months | |
| Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab | Approximately 40 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment | Approximately 40 months | |
| Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with an underlying autoimmune disease treated with ipilimumab for advanced melanoma.
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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 |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Approximately 40 months |
| 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 |