skeletal-related event

skeletal-related event

The metastasis of a tumor to bone, and/or its clinical effects.
Mentioned in ?
References in periodicals archive ?
Under the company's Phase 3 '482 study, XGEVA met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma.
Kaplan-Meier curves of time from PC index date to first skeletal-related event by type of event in patients with metastatic bone disease.
The most concerning untoward event for a person with numerous bony metastases, like Fannie had, is referred to as a skeletal-related event. (16) If Fannie's metastases in her pelvis were to lead to a skeletal-related event, the negative sequelae would include pain and pathological fractures, with subsequent changes in mobility frequency and independence being likely.
In the evaluation of the effectiveness of current pharma-cotherapy, a skeletal-related event (SRE) has been defined as an event involving fracture, orthopaedic intervention, radiation therapy, or spinal cord compression.
Patients treated with denosumab experienced a similar time to first skeletal-related event (SRE), defined as fracture, radiation to bone, surgery to bone, or spinal cord compression, compared with those receiving Novartis AG's Zometa, which was the main goal of the non-inferiority study.
Each skeletal-related event is estimated to cost an average of $7,553 per radiation episode to $88,838 per bone surgery episode (Yong, Onukwugha, & Mullins, 2014), and are often recurring events throughout the course of malignant disease (Hatoum, Lin, Smith.
This US FDA approval is based on data from the company's pivotal Phase 3 '482 study, the largest international multiple myeloma clinical trial ever conducted, which enrolled 1,718 patients.The study met the primary endpoint, demonstrating non-inferiority of XGEVA to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma.
Key Words: Bone metastases, cancer-induced bone disease, cancer therapy induced bone loss, skeletal-related event (SRE), bisphosphonates, RANK ligand inhibitors, zoledronic acid, denosumab, hypocalcemia, osteonecrosis of the jaw, skeletal health.
His report focused on patients who had at least one skeletal-related event. These included 144 patients, about a third of the original population, who had an event before entering the larger trial.