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In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects , an adverse event does not necessarily mean the medication directly caused the problem.
Serious adverse reactions are serious adverse events judged to be related to drug therapy. A SUSAR (suspected unexpected serious adverse reaction) should be reported to a drug regulatory authority under an investigational license by using the CIOMS form (or in some countries an equivalent form).
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.
As of June 2012, 16 of this total of 21 countries have systems for immediate reporting and 9 have systems for periodic reporting of adverse events for on-market agents, while 10 and 8, respectively, have systems for immediate and periodic reporting of adverse events during clinical trials; most of these have PV requirements that rank as "high ...
An adverse event (AE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not the event is associated with the administration of the drug. [1]: 1.2 Adverse Event (AE) An ADR is a special type of AE in which a causative relationship can be shown. [3] ADRs are only one type of medication-related harm.
The clinical hold was initiated following the Company's submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies. To date, three patients ...
An example of a cancer study powered for a combined endpoint is disease-free survival; trial participants experiencing either death or discovery of any recurrence would constitute the endpoint. Overall Treatment Utility is an example of a multidimensional composite endpoint in cancer clinical trials. [8]
By Christy Santhosh (Reuters) -The U.S. health regulator has placed a clinical hold on Iovance Biotherapeutics' trial of its experimental cell therapy in lung cancer patients after a patient death ...