Adverse Event (AE) definition

Adverse Event (AE) means any untoward medical occurrence in a patient treated on a trial protocol, which does not necessarily have a causal relationship with a trial treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a trial treatment, whether or not related to that trial treatment;

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Adverse Event (AE) means 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. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal (investigational) product;

Adverse Event (AE) means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Also known as an Adverse Experience.

Examples of Adverse Event (AE) in a sentence

• A total of **** (****) Adverse Event (AE) qualifiers will be reconciled.

• Adverse Event (AE) Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product).

• Non-serious Adverse Event AE that does not meet the criteria for an SAE.

• Adverse Event (AE) reports and relevant information from source documents should be translated into English as necessary.

• Processing Adverse Event (AE) Reports Topic Task VIFOR Distributor Report Collection The Distributor is responsible for collecting reports of adverse events associated with the Products in the Territory.

• Idenix and Novartis understand and agree that these procedures are intended to comply with 21 CFR 310.305(a), 312.32, 314.80(b), and 314.98 concerning standard written procedures for adverse event reporting in the United States, and all analogous Law applicable to Adverse Event (AE) and Adverse Drug Reaction (ADR) reporting outside the United States.

• Adverse Event (AE) is any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal product/ Alcon Medical Device and which does not necessarily have to have a causal relationship with this treatment.

• Adverse Event (AE) Reporting by Investigator‌ Peri-procedural adverse events, defined as from the start of the EBUS bronchoscopy through the planned surgical resection, will be collected up to 30 days post procedure using the AE paper case report form.

• An Adverse Event (AE) is any untoward medical occurrence in a clinical study patient.

• Safety data include but are not limited to the following types of reports: • Adverse Event (AE) / Adverse Drug Reaction (ADR), associated or not to product quality complaint or falsified/counterfeit products or medical information enquiry.

More Definitions of Adverse Event (AE)

Adverse Event (AE) means any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of the product whether or not related to the product;

Adverse Event (AE) means any untoward medical occurrence in a subject to whom a medicinal product is administered, and which does not necessarily have a causal relationship with this treatment.

Adverse Event (AE) means any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment; and (ii) a “Product Technical Complaint (PTC)” means any report received from a third party (written, electronic or verbal communication) about a potential or alleged failure of a product in its quality (including the identity, durability, reliability, safety, efficacy or performance) or suspect counterfeit which may or may not represent a potential risk to the customer.

Adverse Event (AE) means any untoward medical occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. "Affiliate" means, with respect to either Party, a firm, corporation or other entity which directly or indirectly owns or controls said Party, or is owned or controlled by said Party, or is under common ownership or control with said Party. The word "control" means (i) the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of a legal entity, or (ii) possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities, contract rights, voting rights, corporate governance or otherwise. CONFIDENTIAL Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025 Page 1 [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not material and (II) would be competitively harmful if publicly disclosed.

Adverse Event (AE) means any event resulting from a malfunction or deterioration in characteristic or performance of a medical device or a use error which causes, may be a cause of or contributes to the death or injury of a consumer.