Serious Adverse Events. All serious adverse events, regardless of causality, will be reported in writing and according to Study procedures and the Protocol by the Investigator to MedImmune and/or its designated representatives within twenty-four (24) hours after the Investigator or the relevant sub investigator has become aware of the serious adverse event. Serious adverse events will also be reported to the relevant ethics committee as per the Regulations and relevant ethics committee requirements. Institution and Investigator will provide assistance to MedImmune and/or its designated representatives as requested to clarify the facts and circumstances of each reported serious adverse event. CRO shall report any adverse events to the regulatory authorities and will prepare and submit the annual safety report to the appropriate regulatory authorities. 1.5
Serious Adverse Events. In addition to reporting all AEs (serious and nonserious) meeting the definitions, the investigator must report any occurrence of the following as an SAE: • An ocular infection including a presumed infectious ulcer with any of the following characteristics: o Central or paracentral location o Penetration of Xxxxxx’x membrane o Infiltrates > 2 mm diameter o Iritis o Increase in intraocular pressure o Culture positive for microorganisms o Increasing size or severity at subsequent visits • Any central or paracentral corneal event (such as neovascularization) that results in permanent opacification • Hypopyon • Hyphema • Neovascularization within the central 6 mm of the cornea • Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment visit that fails to resolve • Uveitis (anterior, intermediate, or posterior) • Corneal abrasion affecting ≥ 50% of corneal surface area
Serious Adverse Events. An adverse event is considered serious if it meets the definition of a serious adverse event (SAE) as defined in Section 21.2. Serious adverse events may occur at any time during the study and will be reported as serious regardless of when they occur, provided they meet the definition of a serious adverse event.
Serious Adverse Events. To the best of Rigel’s knowledge, there have been no Serious Adverse Events relating to the Compounds, except for those disclosed to AZ as part of the formal due diligence process between Rigel and AZ prior to the Execution Date.
Serious Adverse Events. The Physician shall immediately communicate the occurrence of serious adverse events as defined in the Protocol (each, an “SAE”) to Biogen Idec as directed in the Protocol. If it becomes necessary to report an SAE to the competent authorities, the author of the report consents to the related disclosure of his or her personal information. 1.7 Závažné nežádoucí příhody Xxxxx xx povinen společnost Biogen Idec neprodleně informovat o výskytu závažných nežádoucích příhod, jak jsou definovány v protokolu (xxxx označovány jako „SAE“), postupem uvedeným v protokolu. Pokud je nezbytné nahlásit SAE příslušným orgánům, autor hlášení souhlasí se souvisejícím předáním svých osobních údajů.
Serious Adverse Events. Serious adverse events that occur at the local institution (Institution B) must be reported to the Institution B’s local IRB as per local institutional policy and should not be reported to Institution A’s IRB.
Serious Adverse Events. An adverse event or suspected adverse reaction is considered “serious” if, in the view of either the investigator or sponsor, it: • results in death (note: death is an outcome, not an event); • is life-threatening; (note: the term "life-threatening" refers to an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event which could hypothetically have caused a death had it been more severe); • requires in-patient hospitalization or prolongs an existing hospitalization; • results in persistent or significant disability/incapacity; • is a congenital anomaly/birth defect; Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious 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. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse. The term severe is a measure of intensity/severity: thus a severe AE is not necessarily serious. For example, nausea of several hours’ duration may be rated as severe, but may not be clinically serious. For the purposes of this study, the following will not be considered as SAEs: • Elective hospitalizations or surgical procedures that are a result of a patient’s pre-existing condition(s) which have not worsened since receiving IMP. Such events triggering the procedure or the hospitalization should still be recorded as AEs in the eCRF; • Hospitalization as requested per protocol for NI-0501infusion and study visits. Any serious clinical AE must be communicated by the Investigator to Sobi AG, by fax or electronic transmission, within 24 hours of awareness. For the initial SAE report, the Investigator should report all available case details concerning the patient and the event, using the Sobi AG SAE reporting standard form. Sobi AG contact information for SAE reporting: Fax: E-mail: Relevant follow-up information on SAEs should be forwarded to Sobi AG as soon as it becomes available. In addition, the Investigator must be available to answer without delay any request for follow-up information or questions Sobi AG may have regarding the SAE. All SAEs will be recorded ...
Serious Adverse Events. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose: • Results in death. • Is life threatening (i.e., the subject was, in the opinion of the PI, at immediate risk of death from the event as it occurred); it does not refer to an event, which hypothetically might have caused death if it were more severe. • Requires or prolongs inpatient hospitalization. • Results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person’s ability to conduct normal life functions). • Results in a congenital anomaly/birth defect. • Requires intervention to prevent permanent impairment or damage. • Is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but based upon appropriate medical judgment, may jeopardize the patient/subject or may require intervention to prevent one of the other outcomes listed above. Adverse events which do not fall into these categories are defined as non-serious. It should be noted that a severe adverse event need not be serious in nature and that a serious adverse event need not, by definition, be severe. In addition, a pre-existing event or condition that results in hospitalization should be recorded on the medical history. The hospitalization would not result in the event or condition being reported as an on study SAE unless, in the view of the PI, hospitalization was prolonged as a result of participation in the clinical trial or was necessary due to a worsening of the pre-existing condition. This is because the onset of the event (the reason for the procedure) occurred before the subject was entered in the trial. Hospitalization for cosmetics, non-emergency prophylaxis, or abortion does not result in an SAE report unless, in the view of the PI, hospitalization for these procedures was prolonged as a result of participation in the clinical trial.
Serious Adverse Events. 16.2.1 It is a condition of participation in this SLA that the Community Pharmacy will give notification, in additional to their statutory obligations, within 24 hours of the information becoming known to them, to the PCT Complaints and Incidents Manager, of all emergency admissions or deaths of any patient covered by this service, where such admission or death is, or may be, due to usage of drugs in question or attributable to relevant underlying medical condition. This is in line with the PCT Incident Reporting Process.
Serious Adverse Events. The Institution shall cause the Physician to comply with all reporting requirements of serious adverse events, as defined in the Protocol (each, an “SAE”), to Biogen Idec, as directed in the Protocol. If it becomes necessary to report an SAE to the competent authorities, the author of the report consents to the related disclosure of his or her personal information.
