▌Adverse event

Any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product¹

▌Adverse event of special interest

An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it. Depending on the nature of the event, rapid communication by the trial sponsor to other parties (eg, regulators) might also be warranted²

▌Adverse drug reaction

A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function³ 

▌Clinical trial

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism, and excretion of one or more investigational medicinal product(s) with the objective of ascertaining its (their) safety and/or efficacy. This includes clinical trials carried out in either one site or multiple sites⁴

▌Database lock point

The date (month and day) designated as the cutoff for data to be included for the periodic update

▌Exposure

The patient-year (or person-year) statistic is used in many clinical studies and statistical assessments of risk. Patient-years are calculated as follows: If 50 patients participated in a study for 10 years, the study would have involved 500 patient-years (50 x 10). This number can be divided by the number of patients who have been affected by a certain condition or event. For example, if two of the patients had back pain, that would be equal to one back pain for every 250 patients over the course of each 1 year of treatment (500/2 = 250)

▌Incidence rate

The incidence rate or person-time rate is the ratio of the number of cases to the total time the population is at risk of disease. The denominator of the person-time rate is the sum of all of the person-years for each study participant⁵

▌MedDRA

MedDRA is a rich and highly specific standardized medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorized for sale⁶

▌Postauthorization or postmarketing

The stage of drug development after a drug or biological product has been approved by a relevant regulatory agency⁷

▌Periodic safety update report

Periodic safety update reports are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorization holders at defined time points during the post-authorization phase⁸

▌Risk

Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm⁹

▌Serious adverse event

A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) is a congenital anomaly/birth defect, or 6) is assessed as medically significant¹⁰

▌Signal

A report or reports of an event with an unknown causal relationship to treatment that is recognized as worthy of further exploration and continued surveillance² OR

Information arising from one or multiple sources, including observations and experiments, which suggests a  potentially new causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action¹¹