Myelodysplastic Syndrome Clinical Trial
Radium-223 Dichloride Long-term Follow-up Program
Summary
Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .
Full Description
This long-term follow up study will enroll subjects who will be transferred from selected interventional, company sponsored trials with radium-223 dichloride (feeder trials).
The primary objectives are to define the long term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; to assess the incidence of bone fractures and bone associated events (e.g., osteoporosis); and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.
Eligibility Criteria
Inclusion Criteria:
Subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial
Exclusion Criteria:
Not applicable to this follow up study
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There are 114 Locations for this study
Anchorage Alaska, 99503, United States
Tucson Arizona, 85704, United States
Plantation Florida, 33324, United States
Indianapolis Indiana, 46202, United States
Ashland Kentucky, 41101, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71103, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48201, United States
Omaha Nebraska, 68130, United States
Syracuse New York, 13210, United States
Pittsburgh Pennsylvania, 15215, United States
Watertown South Dakota, 57201, United States
Seattle Washington, 98109, United States
Darlinghurst New South Wales, 2010, Australia
Westmead New South Wales, 2145, Australia
Fitzroy Victoria, 3065, Australia
Heidelberg Victoria, 3084, Australia
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Porto Alegre Rio Grande Do Sul, 90020, Brazil
Barretos/SP Sao Paulo, 14784, Brazil
São Paulo Sao Paulo, 01246, Brazil
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H2X 0, Canada
Praha 2 , 128 0, Czechia
Helsinki , 00290, Finland
Tampere , FIN-3, Finland
Bordeaux Cedex , 33076, France
Nantes , 44805, France
Nîmes , 30029, France
Saint Cloud , 92210, France
Tours , 37044, France
Villejuif , 94805, France
Ulm Baden-Württemberg, 89091, Germany
Erlangen Bayern, 91054, Germany
München Bayern, 81377, Germany
Rostock Mecklenburg-Vorpommern, 18107, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Mainz Rheinland-Pfalz, 55131, Germany
Magdeburg Sachsen-Anhalt, 39120, Germany
Dresden Sachsen, 01307, Germany
Jena Thüringen, 07747, Germany
Berlin , 10719, Germany
Berlin , 12203, Germany
Bremen , 28277, Germany
Chai Wan , , Hong Kong
Afula , 18341, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petach Tikva , 49414, Israel
Ramat Gan , 52620, Israel
Tel Aviv , 64239, Israel
Zrifin , 70300, Israel
Forlì Cesena Emilia-Romagna, 47014, Italy
Modena Emilia-Romagna, 41124, Italy
Roma Lazio, 00161, Italy
Roma Lazio, 00189, Italy
Milano Lombardia, 20133, Italy
Trento Trentino-Alto Adige, 38100, Italy
Matsuyama Ehime, 791-0, Japan
Sapporo Hokkaido, 003-0, Japan
Sapporo Hokkaido, 060-8, Japan
Kanazawa Ishikawa, 920-8, Japan
Yokohama Kanagawa, 236-0, Japan
Yokohama Kanagawa, 241-8, Japan
Kurashiki Okayama, 701-0, Japan
Osakasayama Osaka, 589-8, Japan
Hidaka Saitama, 350-1, Japan
Kita-Adachigun Saitama, 362-0, Japan
Koto-ku Tokyo, 135-8, Japan
Fukuoka , 811-1, Japan
Kumamoto , 860-0, Japan
Miyazaki , 889-1, Japan
Osaka , 540-0, Japan
Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06273, Korea, Republic of
Daegu , 42601, Korea, Republic of
Incheon , , Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Bodø , 8092, Norway
Oslo , 0424, Norway
Bialystok , 15-02, Poland
Gliwice , 44-10, Poland
Warszawa , 02-78, Poland
Obninsk , 24903, Russian Federation
Singapore , 11907, Singapore
Singapore , 16858, Singapore
Badalona (Barcelona) Barcelona, 08916, Spain
Palma De Mallorca Illes Baleares, 7120, Spain
A Coruña , 15009, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Málaga , 29010, Spain
Pamplona , 31008, Spain
Sevilla , 41013, Spain
Sevilla , 41071, Spain
Umeå , 901 8, Sweden
Kaohsiung , 81362, Taiwan
Taichung , 40705, Taiwan
Taipei , 11217, Taiwan
Taipei , , Taiwan
Taoyuan , 33305, Taiwan
Truro Cornwall, TR1 3, United Kingdom
Plymouth Devon, PL6 8, United Kingdom
Sheffield South Yorkshire, S10 2, United Kingdom
Guildford Surrey, GU2 7, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Coventry Warwickshire, CV2 2, United Kingdom
Bristol , BS2 8, United Kingdom
Cottingham , HU16 , United Kingdom
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