Definition of an Adverse Event. An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g. nausea, chest pain), signs (e.g. tachycardia, enlarged liver) or the abnormal results of an investigation (e.g. laboratory findings, electrocardiogram). In clinical studies an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no IMP has been administered. This definition includes events occurring from the time of the subject giving informed consent until the end of the study (as defined in Section 3.4).
Definition of an Adverse Event. An AE is defined as any untoward medical occurrence in a clinical trial patient administered a medicinal product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not considered related to the investigational medicinal product. A new medical condition or the worsening of a pre-existing condition will be considered an AE. Stable chronic medical conditions such as arthritis that are present prior to study entry and do not worsen during the study will not be considered AEs. Worsening of the disease under study should only be recorded as an AE if the outcome is more serious than would normally be expected from the normal course of the disease in a particular patient. In the study, any event occurring after the clinical trial subject has signed the study Informed Consent (ICF) should be recorded and reported as an AE. Those events occurring prior to drug administration will be considered to be “Non-Treatment-Emergent” AEs and those occurring after drug administration as “Treatment-Emergent” AEs.
Definition of an Adverse Event. An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. An adverse event can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. Accordingly, an adverse event could include any of the following: • intercurrent illnesses • physical injuries • events possibly related to concomitant medication • significant worsening (change in nature, severity, or frequency) of the disease under study or other pre-existing conditions. (NOTE: A condition, recorded as pre-existing, that is intermittently symptomatic [eg, headache] and which occurs during the study should be recorded as an adverse event.) • drug interactions • events occurring during diagnostic procedures or any washout phase of the study • laboratory or diagnostic test abnormalities occurring after the start of the study (ie, after screening and once confirmed by repeat testing) that results in the withdrawal of the patient from the study, requires medical treatment or further diagnostic work-up, or is considered by the study investigator to be clinically significant. NOTE: Abnormal laboratory test results at the screening visit that preclude a patient from entering the study or receiving study treatment are not considered adverse events, but will be recorded to monitor data from patients who do not meet screening criteria.
