Adverse Events means any serious or unexpected side effect, injury, toxicity, or sensitivity reaction, or any adverse drug reaction reports and the severity thereof associated with the Product where the term “serious” as used in this Section refers to an experience which results in death, permanent or substantial disability, a vegetative state, inpatient hospitalization or prolongation of hospitalization, a congenital anomaly, cancer, an overdose, or is life threatening. The term “unexpected” as used in this definition means an adverse drug experience that is not listed in the then current labeling for the Product and includes an event that may be symptomatically or pathophysiologically related to an event listed in the labeling, but differs from the event because of greater severity or specificity.
Adverse Events means (i) any finding from tests in laboratory animals or in vitro that suggests a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity and (ii) any undesirable, untoward or noxious event or experience associated with the clinical, commercial or other use or occurring following administration, of a product in humans, occurring at any dose, whether expected or unexpected and whether or not considered related to or caused by a product, including such an event or experience as occurs in the course of the use of a product in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic action of a product, and including those events or experiences that are required to be reported to the FDA under 21 C.F.R. Sections 312.32 or 314.80 or to Regulatory Authorities under corresponding applicable Law outside the United States.
Adverse Events means any untoward medical occurrence in a patient or clinical investigation subject who is administered a medicinal product, which occurrence may have, but does not necessarily have to have, a causal relationship with the medicinal product, including any occurrence designated as an adverse event under 21 C.F.R. 312.32 and any other Applicable Laws.
Examples of Adverse Events in a sentence
The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Hazards to Health from Use of the Device: See Indications, Contraindications, Warnings, Precautions, and Adverse Events in the device labeling.
Adverse event lists, guidelines, and instructions for AE reporting can be found in Section 7.0 (Adverse Events: List and Reporting Requirements).
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single list of reported and/or potential adverse events (AE) associated with an agent using a uniform presentation of events by body system.
More Definitions of Adverse Events
Adverse Events has the meaning set forth in Section 9.2(o).
Adverse Events has the meaning ascribed to it in Section 3.8.
Adverse Events means those events as defined by the FDA and published in the U. S. Code of Federal Regulations, as amended from time to time and published in the Federal Register, or by the PMDA or any similar definitions under laws within the License Territory relating to adverse drug experiences relating to the use of the Product in the License Territory.
Adverse Events shall have the meaning set out in Section 3.11.
Adverse Events shall have the meaning set forth in Section 4.10 hereof.
Adverse Events. “Adverse Event” (AE) means any untoward medical occurrence, including an exacerbation of a pre-existing condition in a patient or clinical investigation subject administered a BI pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The following data shall also be treated in the same way as AEs in patients or clinical trial subjects using a BI Product: pregnancy (including paternal exposure at conception or in the preceding 3 months), breast feeding whilst using a BI Product, occupational exposure to a BI Product, lack of effect, medication errors (unintended failure in the drug treatment process, prescribing, dispensing, administration), drug overdose (intentional and unintentional), drug abuse or misuse, withdrawal reactions, increased therapeutic response and/or unexpected benefit, drug/drug or drug/food interactions, suspected transmission of an infectious agent via a BI Product, off label use of a BI Product, counterfeit products, any Product Complaint (PC)/quality defect.
Adverse Events means any undesirable event or reaction reported to or known by the Parties regarding the Labeled Drug that is determined to be potentially associated with the use of the Labeled Drug in humans.