Adverse Event of Special Interest (AESI) definition

Adverse Event of Special Interest (AESI) means an AE that requires reporting even if does not meet the standard criteria for seriousness, or it occurs outside the standard AE reporting timeframes for the trial;
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Examples of Adverse Event of Special Interest (AESI) in a sentence

  • 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.

  • This working instructions (WI) document describes the procedures the sites need to follow for reporting Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESI), Disease-Related Events (DREs) and Pregnancies for the EU-SolidAct trial.

  • 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.

  • An Adverse Event of Special Interest (AESI) is one of scientific and medical concern specific to understanding of the investigational product.

  • However, some of those events are listed as Adverse Event of Special Interest (AESI).

  • According to World Health Organization (WHO), an Adverse Event of Special Interest (AESI) is a pre-identified and predefined medically-significant event that has the potential to be causally associated with a vaccine product that needs to be carefully monitored and confirmed by further special studies.

  • An Adverse Event of Special Interest (AESI) is an AE (Serious or Non-Serious) of scientific and medical concern specific to the Sponsor’s product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.

  • The vaccine shall be supplied for programmatic setting and all vaccinations done within the country to be recorded on CoWIN platform and Adverse Event Following Immunization [AEFI], Adverse Event of Special Interest [AESI] shall continue to be monitored.

  • Clarification provided over Adverse Event of Special Interest (AESI) follow-up and reporting of macular degeneration and hypoglycemia.Justification: Clarification provided to ensure consistency in follow-up of macular edema and to eliminate ambiguity over reporting of hypoglycemia as an AESI, ensuring consistency across all subjects.

  • Support the reporting of Adverse Event Following Immunization (AEFI) and Adverse Event of Special Interest (AESI) beyond 30 minutes following vaccine administration, using an in-built monitoring system.

Related to Adverse Event of Special Interest (AESI)

  • Master Servicer Event of Default wherever used herein, means any one of the following events:

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

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

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

  • Bond Event of Default means the occurrence of any of the following (or such event or condition which with notice or lapse of time or both would constitute any of the following):

  • 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;

  • Lease Event of Default Lease Default," "Majority in Interest of Note Holders," "Make-Whole Amount" or "Note Holder," or the percentage of Note Holders required to take or approve any action hereunder, (ii) reduce the amount, or change the time of payment or method of calculation of any amount, of Original Amount, Make-Whole Amount, if any, or interest with respect to any Equipment Note, or alter or modify the provisions of Article III hereof with respect to the order of priorities in which distribution thereunder shall be made as among the Note Holders, the Owner Trustee and Lessee, (iii) reduce, modify or amend any indemnities in favor of the Owner Trustee, the Mortgagee or the Note Holders (except that the Owner Trustee (in its individual capacity) or the Mortgagee, as the case may be, may consent to any waiver or reduction of an indemnity payable to it) or the other Indenture Indemnitees, (iv) consent to any change in the Trust Indenture or the Lease which would permit redemption of Equipment Notes earlier than permitted under Section 2.10 or 2.11 hereof or the purchase or exchange of the Equipment Notes other than as permitted by Section 2.13 hereof, (v) except as contemplated by the Lease or the Participation Agreement, reduce the amount or extend the time of payment of Basic Rent, Stipulated Loss Value, or Termination Value for the Aircraft in each case as set forth in the Lease, or modify, amend or supplement the Lease or consent to any assignment of the Lease, in either case releasing Lessee from its obligations in respect of the payment of Basic Rent, Stipulated Loss Value or Termination Value for the Aircraft or altering the absolute and unconditional character of the obligations of Lessee to pay Rent as set forth in Sections 3 and 16 of the Lease or (vi) permit the creation of any Lien on the Trust Indenture Estate or any part thereof other than Permitted Liens or deprive any Note Holder of the benefit of the Lien of this Trust Indenture on the Trust Indenture Estate, except as provided in connection with the exercise of remedies under Article IV hereof.

  • Master Servicer Termination Test With respect to any Distribution Date, the Master Servicer Termination Test will be failed if the Cumulative Loss Percentage exceeds 4.00%.

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

  • Erroneous Payment Deficiency Assignment has the meaning assigned to it in Section 8.09(d).

  • Owner Event of Default has the meaning set forth in Section 12.2.

  • Servicer Termination Test The Servicer Termination Test is failed if either (x) Cumulative Net Losses for the Mortgage Loans exceed 5.10% of the aggregate Original Class Principal Balance of the Offered Certificates or (y) the most recent Three Month 90-Day Delinquency Rate exceeds 30%.

  • Insurance Agreement Event of Default means an "Event of Default" as defined in the Insurance Agreement.

  • Potential Amortization Event means an event which, with the passage of time or the giving of notice, or both, would constitute an Amortization Event.

  • Intermediate Distribution Frame (IDF means a second frame that augments an existing Main Distribution Frame. Lines or outside cables that do not terminate on the IDF.

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

  • Environmental Event shall have the meaning set forth in Section 12.2.1.

  • Adverse Grantor Trust Event Either: (i) any impairment of the status of the Grantor Trust Pool as a Grantor Trust; or (ii) the imposition of a tax upon the Grantor Trust Pool or any of its assets or transactions.

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

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

  • Amortization Event has the meaning specified in Article IX.

  • Disclosable Special Servicer Fees With respect to any Serviced Loan or related REO Property, any compensation and other remuneration (including, without limitation, in the form of commissions, brokerage fees and rebates) received or retained by the Special Servicer or any of its Affiliates that is paid by any Person (including, without limitation, the Trust, any Mortgagor, any Manager, any guarantor or indemnitor in respect of a Serviced Loan and any purchaser of any Serviced Loan or REO Property (or an interest in an REO Property related to a Serviced Loan Combination, if applicable) in connection with the disposition, workout or foreclosure of any Serviced Loan, the management or disposition of any REO Property, and the performance by the Special Servicer or any such Affiliate of any other special servicing duties under this Agreement, other than (1) any compensation which is payable to the Special Servicer under this Agreement and that is set forth in a report that is part of the CREFC® Investor Reporting Package (IRP) for the applicable period, and (2) any Permitted Special Servicer/Affiliate Fees. For the avoidance of doubt, any compensation or other remuneration that an entity acting in the capacities of both the Master Servicer and Special Servicer is entitled to in its capacity as Master Servicer pursuant to this Agreement will not constitute Disclosable Special Servicer Fees.

  • Servicer Termination Events (or any analogous term under the Lead Securitization Servicing Agreement) include customary market termination events with respect to failure to make advances, failure to timely remit payments to the Non-Lead Note Holders as required hereunder or under the Lead Securitization Servicing Agreement (subject to no more than one business day grace period), failure to timely deposit amounts into any REO Account or to remit to a Servicer for deposit into a related collection or custodial account, failure to deliver (or cause to be delivered) materials or information required in order for each Non-Lead Note Holder or each Non-Lead Depositor to timely comply with its obligations under the Exchange Act, the Securities Act and Form SF-3, and for rating agency downgrades or other triggers with respect to any certificates issued in connection with a Non-Lead Securitization, subject to customary grace periods (provided that, in the case of failures related to the securities laws, such grace periods will not cause a Non-Lead Depositor to fail to comply with the applicable provisions of such securities laws). Upon the occurrence of such a Servicer Termination Event with respect to the Master Servicer affecting a Non-Lead Securitization Note Holder and the Master Servicer is not otherwise terminated pursuant to the Lead Securitization Servicing Agreement, the Master Servicer shall be required, upon the direction of such Non-Lead Securitization Note Holder, to appoint a subservicer with respect to such Non-Lead Securitization Note. Upon the occurrence of a Servicer Termination Event with respect to the Special Servicer affecting a Non-Lead Securitization Note Holder and the Special Servicer is not otherwise terminated pursuant to the Lead Securitization Servicing Agreement, the Trustee shall, upon direction of such Non-Lead Securitization Note Holder, terminate the Special Servicer with respect to, but only with respect to, the Mortgage Loan;

  • Special Servicer Termination Event shall have the meaning given to such term in the Lead Securitization Servicing Agreement.

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

  • Collateral Event of Default means, at any time, the occurrence of either of the following: (A) failure of the Collateral to include, as Eligible Collateral, at least the Maximum Deliverable Number of shares of Common Stock or (B) failure at any time of the Security Interests to constitute valid and perfected security interests in all of the Collateral, subject to no prior or equal Lien, and, with respect to any Collateral consisting of securities or security entitlements (each as defined in Section 8-102 of the UCC), as to which Secured Party has Control, or, in each case, assertion of such by Pledgor in writing.