Adverse Event definition

Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable 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.

Adverse Event has the meaning given in the TGA document “Access to Unapproved Therapeutic Goods – Clinical Trials in Australia” (October 2004) or replacement.

Adverse Event means any untoward medical occurrence in a patient or subject who is administered a Licensed Product, whether or not considered related to the Licensed Product, including, without limitation, any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Licensed Product.

Examples of Adverse Event in a sentence

• Over a similar time period (beginning in June 2021), the Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) database had logged 183 reports for adverse events— including 33 fatalities—that were directly attributed to the consumption of products containing delta-8 or similar synthetically- produced forms of THC.

• In December 2013, SDHB commenced a Serious Adverse Event (SAE) Review.

• All trial interventions are as per the standard care provided within the NHS for mental health.If an Adverse Event (AE) either occurs or is identified during the intervention, it is the responsibility of the therapist to first contact the research team.

• Please refer toSection 7 for details on these studies.AE = Adverse Event; AERP = Adverse Event Reporting Proportion; BT = Blinded Therapy; MedDRA = Medical Dictionary for Regulatory Activities; N = Number of cases; n = Number of events; PT = Preferred Term; SOC = Summary Organ ClassDuring the reporting period, the most frequently reported SAEs in the clinical trials are unexpected32 per the current IB (Version 9.0, dated 18 September 2022).

• DrugFusion Process With Evaluation Step behaviour only occurs if a loop is always looping at least once in every instance execution.The last phase of the process ”Discovery of Adverse Event Rules” is repre- sented in the discovered process by activities from ”SelectItemSet” to ”Gener- ateADERules”.

More Definitions of Adverse Event

Adverse Event means 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;

Adverse Event means any untoward medical occurrence, inappropriate patient management decision, 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 performance study, whether or not related to the device for performance study;

Adverse Event means the occurrence of any event that has had or could reasonably be expected to have a material adverse effect on the business, operations, property, assets or financial condition of the Borrower and the Subsidiaries as a consolidated enterprise or on the ability of the Borrower and the Material Subsidiaries, taken as a whole, to perform their obligations under the Loan Documents.

Adverse Event means 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 medical device.

Adverse Event or “AE” means any untoward medical occurrence in a Human Subject administered Test Article. An AE does not necessarily have a causal relationship with the Test Article, that is, it can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the Test Article, whether or not it is related to it. See FDA Good Clinical Practice Guideline (International Conference on Harmonisation (ICH) E6: “Good Clinical Practice: Consolidated Guidance, 62 Federal Register 25, 691 (1997)).

Adverse Event means any adverse medical occurrence in a patient or clinical investigation subject that is administered a pharmaceutical product, as designated under 21 CFR § 312.32 and any other Applicable Law in the Territory.

Adverse Event means any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An Adverse Event can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.