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| ID | Type | Description | Link |
|---|---|---|---|
| ENCEPP/SDPP/2723 | Other Identifier | Euro. Ntwk. of Ctrs. for Pharmacoepidemiology and Pharmacovigilance |
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The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting
Time Perspective: this study does have a retrospective component involving a subset of patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipilimumab treatment cohort of 1106 prospective participants | |||
| Non-Ipilimumab treatment cohort of 305 prospective participants | |||
| Retrospective cohort of 177 participants |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting | Every 12 months up to 5 years | |
| Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events | Every 12 months up to 5 years | |
| Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab | Every 12 months up to 5 years | |
| Patterns of disease monitoring as observed in a real-world setting | To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination | Every 12 months up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma | Every 12 months up to 5 years | |
| Resource utilization associated with advanced melanoma treatment | Descriptive statistics will be reported for healthcare utilization (inpatient, outpatient, emergency department and other ancillary services) and imputed costs |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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Eligible patients will be selected from approximately 200 medical practice sites (e.g. community-based, office-based, hospital-based, academic setting) in several European Union countries, Central America, North America, and South America, as well as Australia and Israel.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Gilbert | Arizona | 85234 | United States | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34051732 | Result | Dalle S, Mortier L, Corrie P, Lotem M, Board R, Arance AM, Meiss F, Terheyden P, Gutzmer R, Buysse B, Oh K, Brokaw J, Le TK, Mathias SD, Scotto J, Lord-Bessen J, Moshyk A, Kotapati S, Middleton MR. Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study. BMC Cancer. 2021 May 29;21(1):642. doi: 10.1186/s12885-021-08032-y. | |
| 27118102 |
| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
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| Every 12 months up to 5 years |
| Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma | Every 12 months up to 5 years |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Local Institution | Encinitas | California | 92024 | United States |
| Local Institution | La Jolla | California | 92093 | United States |
| Local Institution | Long Beach | California | 90813 | United States |
| Local Institution | Los Angeles | California | 90025 | United States |
| Local Institution | Denver | Colorado | 80218 | United States |
| Local Institution | Washington D.C. | District of Columbia | 20010 | United States |
| Local Institution | Lakeland | Florida | 33085 | United States |
| Local Institution | Miami Beach | Florida | 33140 | United States |
| Local Institution | Orange Park | Florida | 32073 | United States |
| Local Institution | Chicago | Illinois | 60612 | United States |
| Local Institution | Niles | Illinois | 60714 | United States |
| Local Institution | Detroit | Michigan | 48201 | United States |
| Local Institution | Hattiesburg | Mississippi | 39401 | United States |
| Local Institution | Lincoln | Nebraska | 18015 | United States |
| Local Institution | Morristown | New Jersey | 07960 | United States |
| Local Institution | Canton | Ohio | 44178 | United States |
| Mid Ohio Onc/Hem, Inc | Columbus | Ohio | 43206 | United States |
| Local Institution | Columbus | Ohio | 43219 | United States |
| Local Institution | Middletown | Ohio | 45042 | United States |
| Local Institution | Portland | Oregon | 97213 | United States |
| Local Institution | Knoxville | Tennessee | 37920 | United States |
| Local Institution | Everett | Washington | 98201 | United States |
| Local Institution | CABA | 1426 | Argentina |
| Local Institution | CABA | C1417DNT | Argentina |
| Local Institution | CABA | C1426ANZ | Argentina |
| Local Institution | CĂłrdoba | X5006HBF | Argentina |
| Local Institution | Rosario- Santa Fe | S2000KZE | Argentina |
| Local Institution | San Miguel de Tucumán | T4000GTB | Argentina |
| Local Institution | Canberra | Australian Capital Territory | 02605 | Australia |
| Local Institution | Corrimal | New South Wales | 02518 | Australia |
| Local Institution | Lismore | New South Wales | 02480 | Australia |
| Local Institution | Port Macquarie | New South Wales | 02444 | Australia |
| Local Institution | Tamworth | New South Wales | 02340 | Australia |
| Local Institution | Tweeds Head | New South Wales | 02485 | Australia |
| Local Institution | Wagga Wagga | New South Wales | 2650 | Australia |
| Local Institution | Waratah | New South Wales | 02298 | Australia |
| Local Institution | Cairns | Queensland | 4870 | Australia |
| Local Institution | Douglas | Queensland | 04810 | Australia |
| Local Institution | Greenslopes | Queensland | 4120 | Australia |
| Local Institution | Adelaide | South Australia | 05000 | Australia |
| Local Institution | Bedford Park | South Australia | 05042 | Australia |
| Local Institution | Kurralta Park | South Australia | 5037 | Australia |
| Local Institution | Frankston | Victoria | 03199 | Australia |
| Local Institution | Malvern | Victoria | 03144 | Australia |
| Local Institution | Feldkirch | 6800 | Austria |
| Local Institution | Graz | A-8036 | Austria |
| Local Institution | Linz | A-4020 | Austria |
| Local Institution | Salzburg | A-5020 | Austria |
| Local Institution | Sankt Pölten | A-3100 | Austria |
| Local Institution | Vienna | A-1090 | Austria |
| Local Institution | Brasschaat | 2930 | Belgium |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Edegem | 2650 | Belgium |
| Local Institution | Haint Saint Paul | 7100 | Belgium |
| Local Institution | Hasselt | 3500 | Belgium |
| Local Institution | Kortrijk | 8500 | Belgium |
| Local Institution | Leuven | 3000 | Belgium |
| Local Institution | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Local Institution | London | Ontario | N6C 6B5 | Canada |
| Local Institution | Mississauga | Ontario | L5M 2N1 | Canada |
| Local Institution | Windsor | Ontario | N8W 2X3 | Canada |
| Local Institution | Québec | Quebec | G1V 4G2 | Canada |
| Local Institution | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Local Institution | Québec | G1R 2J6 | Canada |
| Local Institution | Bayonne | 64100 | France |
| Local Institution | Besançon | 25000 | France |
| Local Institution | Boulogne | 92104 | France |
| Local Institution | Boulogne-sur-Mer | 62200 | France |
| Local Institution | Brest | 29609 | France |
| Local Institution | Clermont Ferrand Cédex 1 | 63003 | France |
| Local Institution | Dijon | 21079 | France |
| Local Institution | Grenoble Cédex | 38043 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Limoges | 87042 | France |
| Local Institution | Montauban | 82000 | France |
| Local Institution | Mougins | 06250 | France |
| Local Institution | Nouvelle Caledonie | 98849 | France |
| Local Institution | Paris | 75475 | France |
| Local Institution | Pierre-Bénite | 69495 | France |
| Local Institution | Quimper | 29107 | France |
| Local Institution | Soissons | 02209 | France |
| Local Institution | Strasbourg | 67065 | France |
| Local Institution | Vandœuvre-lès-Nancy | 54500 | France |
| Local Institution | Augsburg | 86156 | Germany |
| Local Institution | Bochum | 44791 | Germany |
| Local Institution | Buxtehude | 21614 | Germany |
| Local Institution | Chemnitz | 09117 | Germany |
| Local Institution | Darmstadt | 64297 | Germany |
| Local Institution | Dessau-Roblau | 06847 | Germany |
| Local Institution | Dortmund | 44137 | Germany |
| Local Institution | Dresden | 01307 | Germany |
| Local Institution | DĂĽsseldorf | 40225 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Gera | 07548 | Germany |
| Local Institution | Halle | 06120 | Germany |
| Local Institution | Hamburg | 20099 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Hamburg | 20253 | Germany |
| Local Institution | Hanover | 30625 | Germany |
| Local Institution | Jena | 07743 | Germany |
| Local Institution | Koblenz | 56068 | Germany |
| Local Institution | LĂĽdenscheid | 58515 | Germany |
| Local Institution | Magdeburg | 39120 | Germany |
| Local Institution | Mainz | 55131 | Germany |
| Local Institution | Mannheim | 68167 | Germany |
| Local Institution | Marburg | 35043 | Germany |
| Local Institution | MĂĽnster | 48149 | Germany |
| Local Institution | Plauen | 08529 | Germany |
| Local Institution | Quedlinburg | 06484 | Germany |
| Local Institution | Recklinghausen | 45657 | Germany |
| Local Institution | Rostock | 18055 | Germany |
| Local Institution | Schwäbisch Hall | 74523 | Germany |
| Local Institution | Stuttgart | 70374 | Germany |
| Local Institution | TĂĽbingen | 72076 | Germany |
| Local Institution | WĂĽrzburg | 97080 | Germany |
| Local Institution | CholargĂłs | Athens | 15562 | Greece |
| Local institution | Goudi | Athens | 11527 | Greece |
| Local Institution | Neo Faliro | Athens | 18547 | Greece |
| Local Institution | Heraklion | Crete | 71100 | Greece |
| Local Institution | Neas Efkarpia | Thessaloniki | 56429 | Greece |
| Local Institutio | Alexandroupoli | 68100 | Greece |
| Local Institution | Athens | 11528 | Greece |
| Local Institution | Athens | 15233 | Greece |
| Local Institution | Mezourlo | 41334 | Greece |
| Local Institution | Neo Faliro | 18547 | Greece |
| Local Institution | Wilton | CORK | T12 DC4A | Ireland |
| Local Institution | Cork | Ireland |
| Local Institution | Dublin | Ireland |
| Local Institution | Galway | Ireland |
| Local Institution | Tullamore | Ireland |
| Local Institution | Haifa | 31096 | Israel |
| Local Institution | Tel Aviv | 64239 | Israel |
| Local Institution | Tel Litwinsky | 52621 | Israel |
| Local Institution | Bydgoszcz | 85-796 | Poland |
| Local Institution | Lodz | 93-510 | Poland |
| Local Institution | Warsaw | 02-781 | Poland |
| Local Institution | Wroclaw | 51-124 | Poland |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Donostia / San Sebastian | 20014 | Spain |
| Local Institution | Las Palmas de Gran Canaria | 35016 | Spain |
| Local Institution | Madrid | 28007 | Spain |
| Local Institution | Madrid | 28033 | Spain |
| Local Institution | Madrid | 28034 | Spain |
| Local Institution | Madrid | 28041 | Spain |
| Local Institution | Palma | 07198 | Spain |
| Local Institution | Palma de Mallorca | 07198 | Spain |
| Local Institution | Pamplona | 31008 | Spain |
| Local Institution | Santa Cruz de Tenerife | 35320 | Spain |
| Local Institution | Santa Cruz de Tenerife | 38010 | Spain |
| Local Institution | Santander | 39008 | Spain |
| Local Institution | Santiago de Compostela; A Coruña | 15706 | Spain |
| Local Institution | Seville | 41013 | Spain |
| Local Institution | Terrassa | 08027 | Spain |
| Local Institution | Valladolid | 47012 | Spain |
| Local Institution | Zaragoza | 50009 | Spain |
| Local Institution | Baden | CH-5404 | Switzerland |
| Local Institution | Lugano | CH-6900 | Switzerland |
| Local Institution | Zurich | 8091 | Switzerland |
| Local Institution | Zurich | CH-8091 | Switzerland |
| Local Institution | Rhyl | Denbigshire | LL18 5UJ | United Kingdom |
| Local Institution | London | England | NW3 2QG | United Kingdom |
| Local Institution | Chelmsford, Essex | Essex | CM1 7ET | United Kingdom |
| Local Institution | Southend | Essex | SS0 0RY | United Kingdom |
| Local Institution | Belfast | Ireland | BT9 7AB | United Kingdom |
| Local Institution | Cardiff | South Glamorgan | CF14 2TL | United Kingdom |
| Local Institution | Birmingham | B15 2TH | United Kingdom |
| Local Institution | Bristol | BS2 8ED | United Kingdom |
| Local Institution | Exeter | EX2 5DW | United Kingdom |
| Local Institution | Hull | HU16 5JQ | United Kingdom |
| Local Institution | Leeds | LS9 7TF | United Kingdom |
| Local Institution | Lincoln | LN2 5QY | United Kingdom |
| Local Institution | London | SE1 9RT | United Kingdom |
| Local Institution | London | SW3 6JJ | United Kingdom |
| Local Institution | London | United Kingdom |
| Local Institution | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Local Institution | Oxfordshire | OX3 7LE | United Kingdom |
| Local Institution | Plymouth | PL6 8DH | United Kingdom |
| Local Institution | Poole | BH15 2JB | United Kingdom |
| Local Institution | Preston | PR2 9HT | United Kingdom |
| Local Institution | Staffordshire | ST46QG | United Kingdom |
| Local Institution | Taunton, Somerset | TA1 5DA | United Kingdom |
| Local Institution | Truro, Cornwall | TR1 3LJ | United Kingdom |
| Local Institution | Wolverhampton | WS13 6NH | United Kingdom |
| Local Institution | Yeovil, Somerset | BA21 4AT | United Kingdom |
| Result |
| Middleton MR, Dalle S, Claveau J, Mut P, Hallmeyer S, Plantin P, Highley M, Kotapati S, Le TK, Brokaw J, Abernethy AP. Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study. Cancer Med. 2016 Jul;5(7):1436-43. doi: 10.1002/cam4.717. Epub 2016 Apr 26. |
| Investigator Inquiry form | View source |
| FDA Safety Alerts and Recalls | View source |
| BMS clinical trial educational resource | View source |
| 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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