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The Kaplan–Meier estimator, [1] [2] also known as the product limit estimator, is a non-parametric statistic used to estimate the survival function from lifetime data. In medical research, it is often used to measure the fraction of patients living for a certain amount of time after treatment.
Daratumumab was given priority review status by the US Food and Drug Administration (FDA) for multiple myeloma as a combination therapy (second line). [24] Daratumumab phase III trials for multiple myeloma show great promise in combination therapy with lenalidomide and dexamethasone, [32] as well as with bortezomib and dexamethasone. [33 ...
It was approved for use in the United States in May 2020. [2] [7] [8]Efficacy of daratumumab and hyaluronidase-fihji (monotherapy) was evaluated in the COLUMBA trial (NCT03277105), an open-label non-inferiority trial randomizing 263 participants to daratumumab and hyaluronidase-fihj and 259 to intravenous daratumumab (daratumumab IV). [2]
Survival rate is a part of survival analysis.It is the proportion of people in a study or treatment group still alive at a given period of time after diagnosis. It is a method of describing prognosis in certain disease conditions, and can be used for the assessment of standards of therapy.
Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. [6] Often, no symptoms are noticed initially. [10] As it progresses, bone pain, anemia, renal insufficiency, and infections may occur. [10]
In survival analysis, the hazard ratio (HR) is the ratio of the hazard rates corresponding to the conditions characterised by two distinct levels of a treatment variable of interest. For example, in a clinical study of a drug, the treated population may die at twice the rate of the control population.
There are several software suites available to estimate relative survival rates. Regression modelling can be performed using maximum likelihood estimation methods by using Stata or R. [ 4 ] [ 5 ] For example, the R package cmprsk may be used for competing risk analyses which utilize sub-distribution or 'Fine and Gray' regression methods.
In full generality, the accelerated failure time model can be specified as [2] (|) = ()where denotes the joint effect of covariates, typically = ([+ +]). (Specifying the regression coefficients with a negative sign implies that high values of the covariates increase the survival time, but this is merely a sign convention; without a negative sign, they increase the hazard.)