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.
Sample 1Sample 2Sample 3
Event of Special Interest means any of the following events regardless of its causal relationship to use of the Products: (a)
Sample 1
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.
Sample 1

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.

  • An unreasonable restraint on alienation is void and unenforceable.

  • 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.

  • 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).

  • Adverse Event of Special Interest (AESI)57 LIST OF TABLESTable 1 Schedule of Events 49 LIST OF FIGURESFigure 1.

  • Adverse Event of Special Interest Specific treatment-emergent adverse events of special interest, which may be searched using Standardized or Company MedDRA Queries, will be summarized and include severe cutaneous reactions and anemia.

  • ACS is defined as Adverse Event of Special Interest (AESI), see section 7.1.5. A further AESI is the development of (or worsening of existing) cataracts during treatment with Selinexor.

  • If you submit a Schedule ‘S’ do not show 1099 information as payments to sub−contractors unless such information conforms to the first two conditions.

  • Adverse Event of Special Interest (AESIs): These comprise new onset of Guillain-Barré Syndrome (GBS), Bell’s Palsy, encephalitis / myelitis, optic neuritis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis.

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.

  • 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):

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

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

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

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

  • Owner Event of Default has the meaning set forth in Section 20.3.

  • 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).

  • Company Event of Default bears the meaning ascribed thereto in Section 13.1; “Company Notice of Default” bears the meaning ascribed thereto in Section 13.2;

  • 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;

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

  • Class A Additional Interest shall have the meaning specified in subsection 4.02(a).

  • 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.

  • Class B Additional Interest shall have the meaning specified in subsection 4.02(b).

  • Initial Interest Rate means, as of any date of determination, (a) with respect to each A Note, the Initial Note A Interest Rate and (b) with respect to each B Note, the Initial Note B Interest Rate.

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