Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
255 participants
INTERVENTIONAL
2014-12-18
2024-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Arm 1
The subjects previously enrolled in a selected radium-223 dichloride feeder trial, their treating health care professional, or caregiver will be contacted in 6-month intervals for follow up and query.
Data Collection
No study treatment will be provided in this long term follow up study.
Interventions
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Data Collection
No study treatment will be provided in this long term follow up study.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Anchorage, Alaska, United States
Tucson, Arizona, United States
Plantation, Florida, United States
Indianapolis, Indiana, United States
Ashland, Kentucky, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Omaha, Nebraska, United States
Syracuse, New York, United States
Pittsburgh, Pennsylvania, United States
Watertown, South Dakota, United States
Seattle, Washington, United States
Darlinghurst, New South Wales, Australia
Westmead, New South Wales, Australia
Fitzroy, Victoria, Australia
Heidelberg, Victoria, Australia
Kortrijk, , Belgium
Leuven, , Belgium
Porto Alegre, Rio Grande do Sul, Brazil
Barretos/SP, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Prague, , Czechia
Helsinki, , Finland
Tampere, , Finland
Bordeaux, , France
Nantes, , France
Nîmes, , France
Saint-Cloud, , France
Tours, , France
Villejuif, , France
Ulm, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
München, Bavaria, Germany
Rostock, Mecklenburg-Vorpommern, Germany
Aachen, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Jena, Thuringia, Germany
Berlin, , Germany
Berlin, , Germany
Bremen, , Germany
Chai Wan, , Hong Kong
Afula, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Zrifin, , Israel
Forlì Cesena, Emilia-Romagna, Italy
Modena, Emilia-Romagna, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Trento, Trentino-Alto Adige, Italy
Matsuyama, Ehime, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kanazawa, Ishikawa-ken, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kurashiki, Okayama-ken, Japan
Sayama, Osaka, Japan
Hidaka, Saitama, Japan
Kita-Adachigun, Saitama, Japan
Koto-ku, Tokyo, Japan
Fukuoka, , Japan
Kumamoto, , Japan
Miyazaki, , Japan
Osaka, , Japan
Bodø, , Norway
Oslo, , Norway
Bialystok, , Poland
Gliwice, , Poland
Warsaw, , Poland
Obninsk, , Russia
Singapore, , Singapore
Singapore, , Singapore
Seoul, Seoul Teugbyeolsi, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Daegu, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Badalona (Barcelona), Barcelona, Spain
Palma de Mallorca, Illes Baleares, Spain
A Coruña, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Pamplona, , Spain
Seville, , Spain
Seville, , Spain
Umeå, , Sweden
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Truro, Cornwall, United Kingdom
Plymouth, Devon, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Guildford, Surrey, United Kingdom
Sutton, Surrey, United Kingdom
Coventry, Warwickshire, United Kingdom
Bristol, , United Kingdom
Cottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2014-002407-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16996
Identifier Type: -
Identifier Source: org_study_id
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