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During the 8 years of the MORE and CORE trials, the overall incidence of breast cancer, regardless of invasiveness, was reduced by 58% in the raloxifene group compared with the placebo group (HR = 0.42, 95% CI = 0.29 0.60; P < 0.001).
Similar to data across the three core trials, only two individual SAEs were seen in >1% of patients overall, and these were epilepsy-related: convulsion (n = 36, 3.0%) and status epilepticus (n = 13, 1.1%).
The effect of raloxifene on the incidence of cardiovascular adverse events in postmenopausal women has been reported in the MORE and CORE trials (Dayspring et al 2006; Ensrud et al 2006).
During the 8 years of the MORE and CORE trials, the incidence rate for venous thromboembolic events was 2.2 and 1.3 events per 1000 woman-years for the raloxifene and placebo groups, respectively.
*IM101043, without infliximab arm; **Number represents total number of abatacept exposed patients exposed during both double-blind and open-label; five core trials N = 2,689, overall N = 4,134.
When the MORE and CORE trials were both considered (i.e. analyzing all 8 years of raloxifene therapy) the overall reduction in breast cancer incidence was 66%, with a 76% reduction in estrogen receptor-positive breast cancer.
Similar(48)
The Continuing Outcomes Relevant to Evista (CORE) trial, designed to determine the effect of raloxifene on the incidence of invasive breast cancer, was a 4-year follow-up study to the 4-year Multiple Outcomes of Raloxifene Evaluation (MORE) osteoporosis treatment trial.
In the core trial, the starting dose for both insulins was 10 Units.
313 Auditing involves periodic independent review of core trial processes and documents.
Baseline was defined as the time of randomization in the core trial.
Public contributors will be part of core trial management groups: Trial Steering Committee, the Stakeholder Management Group and the Independent Data Monitoring Committee.
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