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Observational study to evaluate the effectiveness and safety of ipilimumab, administered during the European expanded access programme (EAP) in pretreated patients with advanced (unresectable or metastatic) melanoma.
Minimum age: 18 years old (at time of inclusion in the CA184-367- but 16 for the EAP)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population with condition and without condition | Participating in EAP |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) of patients enrolled in the European ipilimumab EAP | Upto 60 month study period |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics (age, weight, gender, race) of patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period | |
| Clinical characteristics (biological values, stage of initial diagnosis, primary location of melanoma) of patients enrolled in the European ipilimumab EAP collected from medical charts |
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Inclusion Criteria:
Exclusion Criteria:
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Patients participating in Expanded Access Program
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Boston | Massachusetts | 02284-5640 | United States | ||
| Outcome Sciences Inc Dba Outcome |
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| Upto 60 month study period |
| Frequency of discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period |
| Reasons for discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period |
| Treatment outcomes in specific sub-populations of patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period |
| Influence of demographic characteristics (age, weight, gender, race) on effectiveness and safety outcomes among patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period |
| Influence of clinical characteristics (biological values, stage of initial diagnosis, primary location of melanoma) on effectiveness and safety outcomes among patients enrolled in the European ipilimumab EAP collected from medical charts | Upto 60 month study period |
| Boston |
| Massachusetts |
| 02284 |
| United States |
| Local Institution | Linz | 4010 | Austria |
| Local Institution | Brussels | 1090 | Belgium |
| Local Institution | Prague | 100 34 | Czechia |
| Local Institution | Odense C | 5000 | Denmark |
| Local Institution | Rouen | 76000 | France |
| Elbe Klinikum Buxtehude | Buxtehude | 21614 | Germany |
| Local Institution | Debrecen | 4032 | Hungary |
| Local Institution | Dublin | 9 | Ireland |
| Local Institution | Naples | 80131 | Italy |
| Local Institution | Amsterdam | 1066 CX | Netherlands |
| Local Institution | Oslo | 0310 | Norway |
| Local Institution | Moscow | 115478 | Russia |
| Local Institution | Valencia | 46009 | Spain |
| Local Institution | Zurich | 8091 | Switzerland |
| Local Institution | Guildford | Surrey | GU2 7XX | United Kingdom |
| 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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