The approval was based on data from a phase 3 study which included adults with steroid-resistant active PMR who flared on at least 7.5mg per day of prednisone or equivalent during taper.
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Plasma D-dimer had comparable accuracy to CRP, ESR, fibrinogen for diagnosing periprosthetic joint infection in patients with revision hip or knee arthroplasty
In patients whose tumors had ESR1 mutations, elacestrant reduced the risk of progression or death by 45%.
The systematic review and meta-analysis included a broad range of patients with and without chronic kidney disease.
Investigators report results from a systematic review and meta-analysis of data from 23 randomized controlled trials involving 15,144 patients with anemia of CKD.