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. (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.
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.
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).
Serious Adverse Events ....................................................................................
Serious Adverse Events and Never Events This plan does not cover serious adverse events or never events.
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).
A congenital anomaly, death during perinatal period, an induced abortion, or a spontaneous abortion are considered to be an SAE and should be reported in the same time frame and in the same format as all other SAEs (see Reporting of Serious Adverse Events [Section 9.5.4.1]).
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 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.
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. A serious adverse event (SAE) is defined as any AE that meets one or more of the following criteria: • The event is fatal or life-threatening. • The event is permanently disabling (incapacitating or interfering with the ability to resume usual life patterns). • The event results in unplanned inpatient hospitalization or prolongation of existing hospitalization. • The event is a congenital anomaly. • The event requires medical intervention of any kind in order to prevent any of the aforementioned outcomes. A death occurring during the study or within 1 week of stopping the treatment must be reported to the trial safety coordinator. A serious AE is not necessarily severe; for example, an overnight hospitalization for a diagnostic procedure must be reported as a serious AE even though the occurrence is not medically serious. By the same token, a severe AE is not necessarily serious: nausea of several hours’ duration may be rated as severe but may not be considered serious. Any serious adverse event due to any cause that occurs during the investigation, whether or not related to the study medication, must be reported within 24 hours of occurrence or when the investigator becomes aware of the event. The investigator must send a preliminary report of any SAE encountered during the study and for 1 month after a subject has discontinued or completed the study to the trial safety coordinator by fax within 24 hours using an SAE Report Form. The event must also be recorded on the standard AE CRF. Preliminary reports of SAEs must be followed by detailed descriptions later on, including clear photocopies of hospital case reports, consultant reports, autopsy reports, and other documents when requested and applicable. SAE reports must be made whether or not the investigator considers the event to be related to the investigational product. Appropriate remedial measures should be taken to treat the SAE and the response should be recorded. Subjects must be closely followed until sufficient information is obtained to indicate a return to normal status or until the event stabilizes at a level acceptable to the investigator. Clinical, laboratory, and diagnostic measures should be employed as needed in order to determine the etiology of the problem. The results will be reported promptly to the sponsor.
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. 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 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.