This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Administered by subcutaneous injection every 4 weeks (Q4W)
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product.
Time frame: From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Number of Participants With Anti-denosumab Binding Antibodies
A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies.
Time frame: Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.
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Research Site
Capital Federal, Buenos Aires, Argentina
Research Site
Quilmes, Buenos Aires, Argentina
Research Site
Córdoba, Córdoba Province, Argentina
Research Site
Rosario, Santa Fe Province, Argentina
Research Site
Vienna, Austria
Research Site
Namur, Belgium
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
Santo André, São Paulo, Brazil
Research Site
São Paulo, São Paulo, Brazil
...and 54 more locations