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.

  • 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.

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

  • The local IRB must also be informed as noted in section 11.4. 11.7.2 Adverse Event of Special Interest (AESI) Reporting Requirements ARIAD may request additional information to the study sponsor on observed AESIs and this information should be provided in a timely fashion (ie, within 2 business days of the study sponsor awareness).

  • 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.

  • 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.

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

  • 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 Adverse Event of Special Interest (AESI)

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

  • 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.

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

  • 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 10.10(d).

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

  • Servicer Termination Test With respect to any Distribution Date, the Servicer will fail the Servicer Termination Test if the Realized Loss Percentage for the Mortgage Loans exceeds the applicable percentages set forth below with respect to such Distribution Date: January 2006 through December 2007 2.75% January 2008 through December 2008 3.25% January 2009 through December 2009 3.75% January 2010 and thereafter 4.50%

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

  • Potential Amortization Event means any occurrence or event which, with the giving of notice, the passage of time 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.

  • Adverse Grantor Trust Event As defined in Section 10.02(e).

  • 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 has the meaning set forth in Section 13.01(b).

  • 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).

  • Material Event of Default means the occurrence of an Event of Default (as defined in the Senior Unsecured Loan Agreement) under any of the following sections of the Senior Unsecured Loan Agreement: