Serious Adverse Events means an Adverse Event which results in death, is immediately life-threatening, results in persistent and significant disability/incapacity or requires in-patient hospitalization or prolongation of existing hospitalization.
Serious Adverse Events is an Adverse Event that is considered “serious”, because, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening Adverse Event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or a congenital anomaly/birth defect.
Serious Adverse Events means any Adverse Event occurring at any dose in response to the administration of a Licensed Product that: (a) results in death or threatens life; (b) results in persistent or significant disability/incapacity; (c) results in or prolongs hospitalization; (d) results in a congenital anomaly or birth defect; or (e) is otherwise medically significant.
Examples of Serious Adverse Events in a sentence
If the defect is combined with a serious adverse event, the study-site personnel must report the PQC to the sponsor according to the serious adverse event reporting timelines (refer to Section 12.3.2, Serious Adverse Events).
Such information will include the Investigator's Brochure (IB) and information on Suspected Unexpected Serious Adverse Events (SUSARs) for unlicensed products or the Summary of Product Characteristics (SPC) for licensed products.
For each event, the investigator must pursue and obtain adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE (see the Serious Adverse Events section below).
The Sponsor will notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants.
Each Party shall retain all documents, reports, studies and other materials relating to any and all such Serious Adverse Events, as the case may be.
More Definitions of Serious Adverse Events
Serious Adverse Events means any Adverse Event occurring at any dose in response to the administration of a Licensed Product that: (a) results in death or threatens life; (b) results in persistent or significant disability/incapacity; (c) results in or prolongs hospitalization; (d) results in a congenital anomaly or birth defect; or (e) is otherwise medically significant. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Serious Adverse Events. (as defined in Section 8.2.2 below) for the Products of which BMSLC becomes aware shall be submitted to WC within three (3) business days but no more than four (4) days from the date BMSLC first became aware of such Serious Adverse Event. Non-Serious Adverse Events for the Products (as defined in Section 8.2.2 below) that are reported to BMSLC shall be submitted to WC no more than [REDACTED] from the date received by BMSLC; provided, however, that medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent a Serious Adverse Event outcome.
Serious Adverse Events means any Side Effect endangering life to the extent that such Side Effect exposes the patient to a deadly risk requiring or extending hospitalization or causing permanent disability, birth defect, cancer or death.
Serious Adverse Events means any adverse experience that result in any of the following outcomes: death, a life- threatening experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Serious Adverse Events means any adverse experience that result in any of the following outcomes: death, a life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Serious Adverse Events means an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. “Study Drug” means the compound designated LB-100, and all analogs, metabolites and/or active forms thereof, including any derivatives or parts thereof.
Serious Adverse Events. A serious adverse event (SAE) is defined as any AE that meets one or more of the following criteria: