Definition of Adverse Events Sample Clauses

The Definition of Adverse Events clause establishes what constitutes an adverse event within the context of an agreement, typically in clinical trials or product safety monitoring. It outlines specific criteria or examples, such as unexpected medical occurrences, side effects, or injuries related to the use of a product or participation in a study. By clearly defining what qualifies as an adverse event, this clause ensures all parties have a shared understanding, which is essential for consistent reporting, regulatory compliance, and effective risk management.
Definition of Adverse Events. According to International Conference on Harmonization (ICH) guidance E2A, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, an adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which is not necessarily required to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A treatment-emergent AE (TEAE) is an AE that either commenced following initiation of study drug or was present prior to study drug but increased in frequency or severity following initiation of study treatment.
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Definition of Adverse Events. 11.2.1.1. Adverse Event (AE)
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Definition of Adverse Events. An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and does not necessarily have a causal relationship with RBM-007. An AE, therefore, can be an unintended sign (including an abnormal laboratory finding), symptom, or disease that has clinical significance and is temporally associated with the use of a In clinical studies, an undesirable medical condition occurring at any time, including- baseline or pre-treatment period, may be recorded as an AE even if no RBM-007 has been administered. Any significant adverse change in a subject's condition from baseline, regardless of causality, is to be considered an AE, unless the change is determined to be a continuation of a pre-existing condition that is documented in the subject's medical history. However, a clinically significant worsening in severity, intensity, or frequency of a pre-existing condition may indicate an AE. In addition, all conditions that lead to hospitalizations, defined as an overnight hospital stay, are considered as AEs. This includes planned elective surgeries. Lack of efficacy of the i.vt. RBM-007 for the condition being investigated is not considered an AE unless a clinically significant change is assessed by the Clinical Investigator. An elective surgical procedure scheduled or planned prior to study entry is not considered an AE if an overnight hospital stay is not required, and the underlying diagnosis for which surgery is to be performed should be captured in the medical history as a pre-existing condition. The surgical procedure should also include the term "elective" in all reports.
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Definition of Adverse Events. ‌ An adverse event (AE) is any untoward medical occurrence in a subject 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 preexisting conditions. • 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 (i.e., after screening and once confirmed by repeat testing) that results in the withdrawal of the subject from the study, requires medical treatment or further diagnostic work up, or is considered by the study investigator to be clinically significant. The investigator must, for any target or non-target SK related AE, question the subject in detail to determine if there are any confounding factors (e.g., irritation by clothing or activity, sunburn) for any such AE. The investigator should, when certain, report a diagnosis rather than the signs, symptoms or clinically relevant abnormal laboratory values associated with the AE. Otherwise, signs, symptoms or abnormal laboratory values may be used to describe the AE. The investigator must start reporting non-serious AEs starting with the subject’s first study medication treatment continuing through Visit 11.
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Definition of Adverse Events. An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment. The investigator is responsible for ensuring that any AEs observed or reported by the participant are recorded in the medical record The definition of AEs includes worsening of a pre-existing medical condition. Worsening indicates the pre-existing medical condition (e.g., diabetes, migraine headaches, gout) has increased in severity, frequency, and/or duration, and/or has an association with a significantly worse outcome. An AE does not include: medical / surgical procedures (but the condition that leads to the procedure may be and AE; situation where an untoward medical occurrence has not occurred (e.g. hospitalization for cosmetic surgery); overdose of study drug(s) or concomitant medication that does not result in any signs or symptoms (if signs or symptoms are present, then will be recorded as an AE); or underlying disease progression (DME in the study eye). A treatment emergent adverse event (TEAE) is an AE that was not present prior to treatment with the study drug(s), or an event that was present prior to treatment, but worsens either in intensity or frequency following treatment.
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Definition of Adverse Events. According to the April 1996 (E6) International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP), an AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE therefore can be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. If a previously reported AE or pre-existing illness increases in severity or frequency, it will be considered a new event. Any abnormal laboratory value that the Investigator considers clinically significant will be reported as an AE. All AEs determined not to be study drug related will be followed through week 48 and noted as “continuing” if not resolved at the week 48 visit. AEs considered to be study drug related will be followed until they have resolved or stabilized or, in the case of a pre-existing illness, returned to its baseline status recorded prior to the injection of study drug. Subjects that are withdrawn from the study due to an AE or experience an AE that is deemed related to the study drug, will be followed until the event has resolved or has stabilized.
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Definition of Adverse Events 
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Related to Definition of Adverse Events

  • Determination of Adverse Consequences The Parties shall take into account the time cost of money (using the Applicable Rate as the discount rate) in determining Adverse Consequences for purposes of this §8. All indemnification payments under this §8 shall be deemed adjustments to the Purchase Price.

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

  • Absence of Adverse Changes From the date hereof until the Closing, there will have been no material adverse change in the financial or business condition of the Company.

  • Notice of Adverse Change Recipient shall promptly notify OBDD of any adverse change in the activities, prospects or condition (financial or otherwise) of Recipient or the Project related to the ability of Recipient to perform all obligations required by this Contract.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.