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 non-serious) 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 (SAEs) experienced in the course of the study need to be evaluated without delay in the interest of the study patients. Therefore, the Investigator must notify such events immediately to the responsible representative of the CRO and to the Sponsor’s Drug Safety Officer. Further procedures, the definition of SAE, details on notification, including communication data are specified in the study protocol. 9.
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. A serious adverse event (SAE) is any untoward medical occurrence that: • 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; • is medically significant or requires intervention to prevent one or other of the outcomes listed above (note: examples are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization). SAEs are to be reported to NovImmune immediately. The term severe is a measure of intensity/severity: thus a severe adverse event 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 serious adverse events: • 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 should still be recorded as adverse events in the eCRF; • Hospitalization as requested per protocol for NI-0501infusion and study visits. Any serious clinical adverse event or clinically significant abnormal laboratory test value that occurs during the course of the study, irrespective of the treatment received by the subject, must be communicated by the Investigator to NovImmune, 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 NovImmune SAE reporting standard form (see Appendix F). NovImmune contact information for SAE reporting: Relevant follow-up information on SAEs should be forwarded to NovImmune 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 NovImmune may have regarding the SAE. All SAEs will be recorded on the appropriate page of the eCRF. They will be reviewed, evaluated and followed through to resolution by a study physician- Relationship to t...
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 Local Authority, 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 Local Authority Incident Reporting Process.
