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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03138512
Registration number
NCT03138512
Ethics application status
Date submitted
1/05/2017
Date registered
3/05/2017
Titles & IDs
Public title
A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney
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Scientific title
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
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Secondary ID [1]
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2016-004502-34
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Secondary ID [2]
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CA209-914
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 914
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell
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0
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Condition category
Condition code
Cancer
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0
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0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - nivolumab
Treatment: Other - ipilimumab
Treatment: Drugs - nivolumab placebo
Treatment: Drugs - ipilimumab placebo
Experimental: Part A, Arm A: nivolumab + ipilimumab -
Placebo comparator: Part A, Arm B: nivolumab placebo + ipilimumab placebo -
Experimental: Part B, Arm A: nivolumab + ipilimumab -
Placebo comparator: Part B, Arm B: nivolumab placebo + ipilimumab placebo -
Experimental: Part B, Arm C: nivolumab + ipilimumab placebo -
Treatment: Other: nivolumab
Specified dose on specified days
Treatment: Other: ipilimumab
Specified dose on specified days
Treatment: Drugs: nivolumab placebo
Specified dose on specified days
Treatment: Drugs: ipilimumab placebo
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease-free survival (DFS) as assessed by BICR (Part A and Part B)
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Assessment method [1]
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Timepoint [1]
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Up to 10 years
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Secondary outcome [1]
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Overall Survival (OS) (Part A and Part B)
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Assessment method [1]
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Timepoint [1]
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Up to 10 years
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Secondary outcome [2]
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Incidence of Adverse Events (AEs) (Part A and Part B)
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Assessment method [2]
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Timepoint [2]
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Up to 100 days after the last dose of study treatment
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Secondary outcome [3]
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Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C)
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Assessment method [3]
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Timepoint [3]
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Up to 10 years
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Eligibility
Key inclusion criteria
* Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
* Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
* Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
* Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
* Women must agree to follow methods of contraception, if applicable
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants with an active known or suspected autoimmune disease
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
* History of allergy or hypersensitivity to study drug components
* Participants with a condition requiring systemic treatment with corticosteroids
* Participants who have received a live/attenuated vaccine within 30 days of first treatment
Other protocol-defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2024
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Sample size
Target
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Accrual to date
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Final
1653
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0215 - Macquarie Park
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Local Institution - 0032 - Northmead
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Local Institution - 0036 - Randwick
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Local Institution - 0035 - St Leonards
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Local Institution - 0113 - South Brisbane
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Local Institution - 0213 - Southport
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Local Institution - 0034 - Elizabeth Vale
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Local Institution - 0033 - Clayton
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Local Institution - 0214 - Heidelberg
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Recruitment hospital [10]
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Local Institution - 0031 - Murdoch
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Recruitment postcode(s) [1]
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2109 - Macquarie Park
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2152 - Northmead
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2031 - Randwick
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2065 - St Leonards
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4101 - South Brisbane
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4215 - Southport
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5112 - Elizabeth Vale
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0 - Clayton
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3084 - Heidelberg
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Recruitment postcode(s) [10]
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6150 - Murdoch
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Recruitment outside Australia
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Zwolle
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Poland
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Bydgoszcz
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Poland
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Wroclaw
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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Cluj
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Romania
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Craiova
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Romania
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Ia?i
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint-Petersburg
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Singapore
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Central Singapore
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Caceres
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Spain
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Cordoba
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Lugo
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Spain
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Madrid
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Spain
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Sabadell
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Spain
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Sevilla
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Switzerland
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Chur
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Switzerland
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Sankt Gallen
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Switzerland
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Zuerich
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Turkey
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Ankara
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Turkey
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Istanbul
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United Kingdom
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Hampshire
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United Kingdom
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Manchester
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United Kingdom
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Northwood
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United Kingdom
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Preston
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United Kingdom
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
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Trial website
https://clinicaltrials.gov/study/NCT03138512
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Trial related presentations / publications
Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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/NCT03138512