Serious Adverse Events definition
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 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 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
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.
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.
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.
All fields with additional or changed information must be completed and the report form should be forwarded to the Study Contact for Reporting Serious Adverse Events as soon as possible but latest within 7 calendar days after receipt of the new information.
This Agreement is for FIVE (5) years, subject to prior termination as herein provided.
More Definitions of Serious Adverse Events
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 shall have the same meaning as given in the Phase 2B Clinical Trial protocol and the drug relatedness assessment shall be determined by the primary investigator of the Phase 2B Clinical Trial in their sole discretion;
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 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. 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Serious Adverse Events. (as defined in Section 8.2.2 below) for the Products of which WSP becomes aware shall be submitted to WC within [REDACTED] but no more than [REDACTED] from the date WSP 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 WSP shall be submitted to WC no more than [REDACTED] from the date received by WSP; 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. A serious adverse event (SAE) is defined as any AE that meets one or more of the following criteria:
Serious Adverse Events. (as defined in Section 8.2.2 below) for the Products of which WSP becomes aware shall be submitted to WC within three (3) business days but no more than four (4) days from the date WSP 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 WSP shall be submitted to WC no more than one (1) month from the date received by WSP; 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.