Ad
related to: adverse events in clinical trials
Search results
Results From The WOW.Com Content Network
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.
In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose Results in death; Is life-threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability/incapacity
Many clinical trials, now extending beyond oncology, encode their observations based on the CTCAE system. It uses a range of grades from 1 to 5. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is:
For example, a pain-relief drug is tested on 1500 human subjects, and no adverse event is recorded. From the rule of three, it can be concluded with 95% confidence that fewer than 1 person in 500 (or 3/1500) will experience an adverse event. By symmetry, for only successes, the 95% confidence interval is [1−3/ n,1].
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.
People in the 592 HbA1c trials had a mean age of 58.9 years (42.3% female), and for the 23 trials that reported major adverse cardiovascular events, the mean age was 64 years (35.3% female).
Also known as AE (adverse event) or SAE (serious AE) reporting from clinical trials, safety information from clinical studies is used to establish a drug's safety profile in humans and is a key component that drug regulatory authorities consider in the decision-making as to whether to grant or deny market authorization (market approval) for a drug.
In many countries, adverse effects are required by law to be reported, researched in clinical trials and included into the patient information accompanying medical devices and drugs for sale to the public. Investigators in human clinical trials are obligated to report these events in clinical study reports. [5]