Adverse Event (AE. Monitoring
Adverse Event (AE. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this 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 product, whether or not related to the investigational product. Worsening of a pre-treatment event, after initiation of tazemetostat, must be recorded as a new AE. For example, if a subject experiences mild intermittent dyspepsia prior to dosing tazemetostat, but the dyspepsia becomes severe and more frequent after the first dose of tazemetostat, a new AE of severe worsening dyspepsia (with the appropriate date of onset) should be recorded in the eCRF. “Lack of efficacy” or “failure of an expected pharmacological action” per se is not to be reported as an AE or SAE. However, any signs and symptoms and/or clinical sequelae resulting from “lack of efficacy” will be reported as an AE or SAE, if they fulfill the definition of an AE or SAE. Events that do not meet the definition of an AE include: • Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that leads to the procedure is an AE. • Situations where an untoward medical occurrence did not occur (social and/or convenience admission to a hospital). • Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study that do not worsen.
Adverse Event (AE. An adverse event is defined as any untoward medical occurrence experienced by or worsening of a pre-existing condition of a subject during this trial in relation to the investigational device or study procedure. The assessment whether a detected adverse event is related to the investigational product or procedure is done by the specific site investigator. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device. This definition includes events that are anticipated as well as unanticipated events, and also includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Adverse Event (AE. Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Therefore an AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal products, whether or not considered related to the medicinal product. A valid report of an adverse event must contain the following minimum information: • patient identification i.e. one or more of the following: initials; identification number such as clinical trial number; age or date of birth; gender • an identifiable source (reporter’s name or initials and/or address and/or qualifications e.g. physician, dentist, pharmacist, nurse) • suspected drug(s) • a specific adverse event
Adverse Event (AE. An AE is any untoward medical occurrence in a patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this 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 a medicinal product, whether or not related to the medicinal product. This includes the following: an AE occurring in the course of the use of a drug product in professional practice; an AE occurring from drug overdose whether accidental or intentional; an AE occurring from drug abuse; an AE occurring from drug withdrawal; and any failure of expected pharmacological action.
Adverse Event (AE. An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug-related. This includes an exacerbation of a pre-existing condition. AEs include: • Worsening (change in nature, severity, or frequency) of conditions present at the onset of the study • Intercurrent illnesses • Drug interactions • Events related to or possibly related to concomitant medications • Abnormal laboratory values (this includes significant shifts from baseline within the range of normal that the Investigator considers to be clinically important) • Clinically significant abnormalities in PE, xxxxx xxxxx, and weight Note that PD should not be reported as an AE unless it is considered to be drug-related by the Investigator. All AEs, including AEs attributed to study procedures, occurring from the time of study informed consent until 30 days after last study treatment must be reported on the AE eCRF, regardless of the severity or relationship to study drug. Only AEs which are considered related to a study procedure (ie blood draw or fresh tumor biopsy) will be captured during the pre- screening period, ie from the time of signing the pre-screening consent (if one is utilized) until the signing of the main study informed consent, or until the patient is determined to be a screen failure. The Investigator should treat patients with AEs appropriately and observe them at suitable intervals until the events stabilize, return to baseline or resolve. AEs may be discovered through observation or examination of the patient, questioning of the patient, complaint by the patient, or by abnormal clinical laboratory values. In addition, AEs may also include laboratory values that become significantly out of range. Such abnormal laboratory values or test results constitute AEs if they induce clinical signs or symptoms, are considered clinically significant (eg, cause study drug discontinuation or constitutes in and of itself an SAE, or require therapy, and should be recorded on the AE eCRF under the signs, symptoms or diagnosis associated with them. In the event of an out-of-range value, the laboratory test should be repeated until it returns to normal or baseline or can be explained and the patient’s safety is not at risk.
