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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02312960




Registration number
NCT02312960
Ethics application status
Date submitted
5/12/2014
Date registered
9/12/2014

Titles & IDs
Public title
Radium-223 Dichloride Long-term Follow-up Program
Scientific title
A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride
Secondary ID [1] 0 0
2014-002407-25
Secondary ID [2] 0 0
16996
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasm Metastasis / Bone and Bones 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Data Collection

Other: 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.


Other interventions: Data Collection
No study treatment will be provided in this long term follow up study.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of radium-223 dichloride related Adverse Events
Timepoint [1] 0 0
Up to 7 years
Primary outcome [2] 0 0
Severity of radium-223 dichloride related Adverse Events
Timepoint [2] 0 0
Up to 7 years
Primary outcome [3] 0 0
Incidence of radium-223 dichloride related Serious Adverse Events
Timepoint [3] 0 0
Up to 7 years
Primary outcome [4] 0 0
Incidence of placebo-related Adverse Events
Timepoint [4] 0 0
Up to 7 years
Primary outcome [5] 0 0
Severity of placebo-related Adverse Events
Timepoint [5] 0 0
Up to 7 years
Primary outcome [6] 0 0
Incidence of placebo-related Serious Adverse Events
Timepoint [6] 0 0
Up to 7 years
Primary outcome [7] 0 0
Incidence of leukemia
Timepoint [7] 0 0
Up to 7 years
Primary outcome [8] 0 0
Incidence of myelodysplastic syndrome
Timepoint [8] 0 0
Up to 7 years
Primary outcome [9] 0 0
Incidence of aplastic anemia
Timepoint [9] 0 0
Up to 7 years
Primary outcome [10] 0 0
Incidence of primary bone cancer
Timepoint [10] 0 0
Up to 7 years
Primary outcome [11] 0 0
Incidence of any other new primary malignancy
Timepoint [11] 0 0
Up to 7 years
Primary outcome [12] 0 0
Incidence of bone fractures
Timepoint [12] 0 0
Up to 7 years
Primary outcome [13] 0 0
Incidence of bone-associated events
Timepoint [13] 0 0
Up to 7 years
Primary outcome [14] 0 0
Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy
Timepoint [14] 0 0
Up to 7 years
Primary outcome [15] 0 0
Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy
Timepoint [15] 0 0
Up to 7 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Not applicable to this follow up study

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2024
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Westmead
Recruitment hospital [3] 0 0
- Fitzroy
Recruitment hospital [4] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Belgium
State/province [15] 0 0
Kortrijk
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio Grande Do Sul
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 2
Country [22] 0 0
Finland
State/province [22] 0 0
Helsinki
Country [23] 0 0
Finland
State/province [23] 0 0
Tampere
Country [24] 0 0
France
State/province [24] 0 0
Bordeaux Cedex
Country [25] 0 0
France
State/province [25] 0 0
Nantes
Country [26] 0 0
France
State/province [26] 0 0
Nîmes
Country [27] 0 0
France
State/province [27] 0 0
Saint-Cloud
Country [28] 0 0
France
State/province [28] 0 0
Tours
Country [29] 0 0
France
State/province [29] 0 0
Villejuif
Country [30] 0 0
Germany
State/province [30] 0 0
Baden-Württemberg
Country [31] 0 0
Germany
State/province [31] 0 0
Bayern
Country [32] 0 0
Germany
State/province [32] 0 0
Mecklenburg-Vorpommern
Country [33] 0 0
Germany
State/province [33] 0 0
Nordrhein-Westfalen
Country [34] 0 0
Germany
State/province [34] 0 0
Rheinland-Pfalz
Country [35] 0 0
Germany
State/province [35] 0 0
Sachsen-Anhalt
Country [36] 0 0
Germany
State/province [36] 0 0
Sachsen
Country [37] 0 0
Germany
State/province [37] 0 0
Thüringen
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Bremen
Country [40] 0 0
Hong Kong
State/province [40] 0 0
Chai Wan
Country [41] 0 0
Israel
State/province [41] 0 0
Afula
Country [42] 0 0
Israel
State/province [42] 0 0
Haifa
Country [43] 0 0
Israel
State/province [43] 0 0
Jerusalem
Country [44] 0 0
Israel
State/province [44] 0 0
Petach Tikva
Country [45] 0 0
Israel
State/province [45] 0 0
Ramat Gan
Country [46] 0 0
Israel
State/province [46] 0 0
Tel Aviv
Country [47] 0 0
Israel
State/province [47] 0 0
Zrifin
Country [48] 0 0
Italy
State/province [48] 0 0
Emilia-Romagna
Country [49] 0 0
Italy
State/province [49] 0 0
Lazio
Country [50] 0 0
Italy
State/province [50] 0 0
Lombardia
Country [51] 0 0
Italy
State/province [51] 0 0
Trentino-Alto Adige
Country [52] 0 0
Japan
State/province [52] 0 0
Ehime
Country [53] 0 0
Japan
State/province [53] 0 0
Hokkaido
Country [54] 0 0
Japan
State/province [54] 0 0
Ishikawa
Country [55] 0 0
Japan
State/province [55] 0 0
Kanagawa
Country [56] 0 0
Japan
State/province [56] 0 0
Okayama
Country [57] 0 0
Japan
State/province [57] 0 0
Osaka
Country [58] 0 0
Japan
State/province [58] 0 0
Saitama
Country [59] 0 0
Japan
State/province [59] 0 0
Tokyo
Country [60] 0 0
Japan
State/province [60] 0 0
Fukuoka
Country [61] 0 0
Japan
State/province [61] 0 0
Kumamoto
Country [62] 0 0
Japan
State/province [62] 0 0
Miyazaki
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Seoul Teugbyeolsi
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Daegu
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Incheon
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Seoul
Country [67] 0 0
Norway
State/province [67] 0 0
Bodø
Country [68] 0 0
Norway
State/province [68] 0 0
Oslo
Country [69] 0 0
Poland
State/province [69] 0 0
Bialystok
Country [70] 0 0
Poland
State/province [70] 0 0
Gliwice
Country [71] 0 0
Poland
State/province [71] 0 0
Warszawa
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Obninsk
Country [73] 0 0
Singapore
State/province [73] 0 0
Singapore
Country [74] 0 0
Spain
State/province [74] 0 0
Barcelona
Country [75] 0 0
Spain
State/province [75] 0 0
Illes Baleares
Country [76] 0 0
Spain
State/province [76] 0 0
A Coruña
Country [77] 0 0
Spain
State/province [77] 0 0
Madrid
Country [78] 0 0
Spain
State/province [78] 0 0
Málaga
Country [79] 0 0
Spain
State/province [79] 0 0
Pamplona
Country [80] 0 0
Spain
State/province [80] 0 0
Sevilla
Country [81] 0 0
Sweden
State/province [81] 0 0
Umea
Country [82] 0 0
Taiwan
State/province [82] 0 0
Kaohsiung
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taichung
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taipei
Country [85] 0 0
Taiwan
State/province [85] 0 0
Taoyuan
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Cornwall
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Devon
Country [88] 0 0
United Kingdom
State/province [88] 0 0
South Yorkshire
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Surrey
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Warwickshire
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Bristol
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Cottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02312960