Event of Special Interest definition

Event of Special Interest means an event that is of special interest to health authorities, and therefore required to be recorded by Alcon, including use error, abnormal use, product tampering, product counterfeiting and product theft.
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Event of Special Interest means any of the following events regardless of its causal relationship to use of the Products: (a) seizure: patient experiences a seizure; (b) pregnancy: a patient receiving therapy with the Products is pregnant or becomes pregnant; (c) worsening illness or suicide attempt/suicidal ideation: a patient is hospitalized due to worsening illness, makes a suicide attempt or the occurrence of a completed suicide; or (d) Device-Device Co-Administration: lf TMS Therapy is administered in a patient with an implanted medical device and a device- device interaction is suspected or occurs.
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Event of Special Interest means any of the following events regardless of its causal relationship to use of the Products: (
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Examples of Event of Special Interest in a sentence

  • Any AE that meets protocol-defined serious criteria or meets the definition of Adverse Event of Special Interest that require expedited reporting must be submitted immediately (within 24 hours of awareness) to OSRO Safety using the CCR SAE report form.

  • Any AE that meets protocol-defined serious criteria or meets the definition of Adverse Event of Special Interest that require expedited reporting must be submitted immediately (within 24 hours of awareness) to OSRO Safety using the CCR SAE report form.All SAE reporting must include the elements described in 8.2.SAE reports will be submitted to the Center for Cancer Research (CCR) at: OSROSafety@mail.nih.gov and to the CCR PI and study coordinator.

  • An Adverse Event of Special Interest (AESI) (serious or non-serious) is one of scientific and medical concern specific to the sponsor’s product or programme, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.

  • Any AE that meets protocol-defined serious criteria or meets the definition of Adverse Event of Special Interest that require expedited reporting must be submitted immediately (within 24 hours of awareness) to OSRO Safety using the CCR SAE report form.All SAE reporting must include the elements described in section 8.2.SAE reports will be submitted to the Center for Cancer Research (CCR) at: OSROSafety@mail.nih.gov and to the CCR PI and study coordinator.

  • It is anticipated that most patients will have proceeded to further lymphoma treatment by the 3 month timepoint.Adverse events meeting the definition of a Serious Adverse Event (SAE) or Adverse Event of Special Interest (AESI) must also be reported to UCL CTC using the trial specific SAE Report.

  • Seizures in connection with vaccinations are among the adverse events of special interest (Adverse Event of Special Interest, AESI), which are generally (by convention) classified as serious events after vaccination for the reporting and monitoring of the safety of vaccines, even if the formal criteria as defined in the Medicinal Products Act are not met.A total of 1,169 suspected cases of seizures were reported to the Paul-Ehrlich- Institut after vaccination with a COVID-19 vaccine through 30 June 2022.

  • The investigator must also provide with a copy (MedWatch 3500A form) of any FDA submissions (expedited 7- Day or 15-Day initial and follow-up safety reports) within 24 hours of submission.Thromboembolic events will be considered Adverse Event of Special Interest (AESI) and will also be reported at the above number or email.

  • Study CT-P10 3.4: Adverse Event of Special Interest – Infections and Infestations Study CT-P10 3.4CT-P10 N=130 n(%)Source: FDA Clinical Reviewer Clinical Reviewer Comment: Infections occurred more frequently in study CT-P10 3.3, likely related to the more severe patient population (advanced follicular lymphoma vs.

  • Study VLA1553-303 collected long-term safety by following-up any Adverse Event of Special Interest (AESI) from the preceding study and collecting new- onset SAE.

  • Adverse Event of Special Interest (AESI): An adverse event of special interest is an adverse event (serious or non-serious) of scientific and medical concern specific to the Sponsor’s product or program, regardless of causality, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.

Related to Event of Special Interest

  • Special Interest shall have the meaning assigned thereto in Section 2(c) hereof.

  • Payment Event of Default means an Event of Default specified in Section 7.1(a).

  • Declaration Event of Default means an “Event of Default” as defined in the Declaration.

  • Acceleration Event of Default means an Event of Default under Section 5.1(a), (d), (e) or (f), whatever the reason for such Acceleration Event of Default and whether it shall be voluntary or involuntary or be effected by operation of law or pursuant to any judgment, decree or order of any court or any order, rule or regulation of any administrative or governmental body.

  • Mortgage Loan Event of Default means an “Event of Default” under and as defined in the Mortgage Loan Agreement.

  • Servicer Event of Default One or more of the events described in Section 7.01.

  • Master Servicer Event of Default One or more of the events described in Section 7.01.

  • Issuer Event of Default means the occurrence of any of the following events:

  • Owner Event of Default shall have the meaning set forth in Section 18.3.

  • Triggering Event of Default means (i) any Event of Default with respect to an obligation of the Mortgage Loan Borrower to pay money due under the Mortgage Loan or (ii) any non-monetary Event of Default as a result of which the Mortgage Loan becomes a Specially Serviced Mortgage Loan (which, for clarification, shall not include any imminent Event of Default (i.e., subclause (vii) of the definition of Special Servicing Loan Event)).

  • Financial Interest means either:

  • Note Event of Default means any “Event of Default” specified in Section 5.1 of the Indenture.

  • Loan Event of Default means any of the events specified in Section 5.1 of the Loan Agreement, provided that any requirement for the giving of notice, the lapse of time, or both, or any other condition, event or act has been satisfied.

  • PTC Event of Default means, with respect to each Trust Agreement, the failure to pay within 10 Business Days after the due date thereof: (i) the outstanding Pool Balance of the applicable Class of Certificates on the Final Legal Distribution Date for such Class or (ii) interest due on such Certificates on any Distribution Date (unless the Subordination Agent shall have made an Interest Drawing or a withdrawal from the Cash Collateral Account relating to a Liquidity Facility for such Class, with respect thereto in an aggregate amount sufficient to pay such interest and shall have distributed such amount to the Trustee entitled thereto).

  • Debenture Event of Default means an "Event of Default" as defined in the Indenture.

  • Lease Event of Default shall have the meaning specified in Section 17.1 of the Lease.

  • Potential Issuer Event of Default means any condition, event or act which, with the lapse of time and/or the issue, making or giving of any notice, certification, declaration, demand, determination and/or request and/or the taking of any similar action and/or the fulfilment of any similar condition, would constitute an Issuer Event of Default;

  • Collateral Senior Additional Interest shall have the meaning specified in subsection 4.02(d).

  • Event of Servicer Termination With respect to the Servicing Agreement, a Servicing Default as defined in Section 6.01 of the Servicing Agreement.

  • Guarantor Event of Default means the occurrence of any “Event of Default” under and as defined in the Performance Guaranty.

  • Liquidity Event of Default with respect to any Liquidity Facility, has the meaning assigned to such term in such Liquidity Facility.

  • Collateral Event of Default has the meaning set forth in Section 13.01(b).

  • Guarantee Event of Default means a default by the Guarantor on any of its payment or other obligations under this Guarantee.

  • Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights, license agreements, and royalties from such rights). The term does not include:

  • Potential Event of Default means any event which, with the giving of notice or the lapse of time or both, would constitute an Event of Default.

  • O & M Default means any default on the part of the Power Producer for a continuous period of ninety (90) days to (i) operate and/or (ii) maintain (in accordance with Prudent Utility Practices), the Project at all times.