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The primary endpoint of a clinical trial is the endpoint for which the trial is powered. Secondary endpoints are additional endpoints, preferably also pre-specified, for which the trial may not be powered.
Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the primary endpoint. Measurable disease – the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
The SCoRS assessment collects information generated from three different sources: An interview with the patient; An interview with an informant for the patient (ideally a person who has regular contact with the patient in everyday situations, such as a family member, friend, or social worker)
A surrogate endpoint of a clinical trial is a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives. Changes induced by a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint. [8]
Turquoise II was an open-label, randomized trial which had a primary endpoint of cure (SVR 12) rate in patients with compensated cirrhosis and either HCV GT1a or GT1b and both treatment arms were given Viekira Pak and (RBV). The two treatment arms differed by length of treatment: subjects were randomly assigned to receive treatment for either ...
Ridaforolimus (also known as AP23573 and MK-8669; formerly known as deforolimus [1]) is an investigational targeted and small-molecule inhibitor of the protein mTOR, a protein that acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival, integrating signals from proteins, such as PI3K, AKT and PTEN known to be important to malignancy.
Major adverse cardiovascular events (MACE, or major adverse cardiac events) is a composite endpoint frequently used in cardiovascular research. [ 1 ] [ 2 ] Despite widespread use of the term in clinical trials, the definitions of MACE can differ, which makes comparison of similar studies difficult.
The study is investigating the effect of setanaxib in PBC patients who have an intolerance or inadequate response to ursodeoxycholic acid (UDCA), and liver stiffness of ≥8.8 kilopascals (kPa).The primary endpoint is reduction in alkaline phosphatase (ALP). The first part of the trial will have three arms – a placebo arm and two dosing arms ...