Adverse Events of Special Interest Sample Clauses

Adverse Events of Special Interest. There are no AEs of special interest (serious or nonserious) associated with MIRV.
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Adverse Events of Special Interest. Adverse events of special interest represent a subset of adverse events that include autoimmune diseases and other systemic disorders of interest which could potentially have an autoimmune aetiology. Adverse events of special interest are listed below. The Principal Investigator should use clinical and scientific judgment in deciding whether other adverse events (i.e., events not listed here) could have an autoimmune origin and should therefore be reported as adverse events of special interest.
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Adverse Events of Special Interest. The effects of Dysport® and all BTX products may spread from the area of injection to produce symptoms consistent with BTX effects. These symptoms have been reported hours to weeks after injection. Remote spread of toxin that affects swallowing and breathing can be life threatening, and there have been reports of death. The risk of symptoms is increased in subjects who have underlying conditions (e.g. disorders of the neuromuscular junction) that would predispose them to these symptoms. Dysport® is contraindicated in individuals with known hypersensitivity to any BTX preparation or to any of the components in the formulation. Adverse events of special interest (AESIs) for Dysport® are AEs that suggest a possible remote spread of effect of the toxin or hypersensitivity. A list of preferred terms of AESIs is provided in the Statistical Analysis Plan (SAP). All AEs will be monitored by the sponsor to determine if they meet the criteria of AESIs. These AESIs will be further analysed to determine if there is a plausible possibility that they represent distant spread of toxin or hypersensitivity. In order to perform the analysis, variables including alternate aetiology (medical history, concomitant medication, or diagnosis which could account for the symptoms), location of Dysport® administration, and temporal relationship to Dysport® administration will be considered by the sponsor.
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Adverse Events of Special Interest. Grade ≥ 2 Congestive Heart Failure • Grade ≥ 2 QT prolongation • Any grade syncope • Grade ≥ 3 cognitive disturbances • Any grade fractures • Cases of potential drug-induced seniorů pokud jsou spojené s výskytem nežádoucí příhody, o Nedostatečná účinnost spojená či bez spojení s výskytem nežádoucí příhody, o Pokud není jinak určeno v protokolu, informace o podezření na přenos infekčního agens prostřednictvím přípravku /STIAMP/. Poznámka: takové informace jsou vždy považovány za nežádoucí příhodu, o Lékové interakce, včetně interakcí lék/potravina, lék/zdravotnický prostředek a lék/alkohol. Poznámka: takové informace jsou vždy považovány za nežádoucí příhodu. • Stížnosti na produkt (spojené nebo bez spojení s výskytem nežádoucí příhody). Lékař zašle společnosti Roche všechna nezávažná ADR jednou za měsíc. Pro schválené léčivé přípravky bude Lékař sbírat všechny AE a specifické okolnosti vypsané výše (spojené nebo bez spojení s nežádoucí příhodou) a bude je předávat společnosti Roche do jednoho (1) pracovního dne od zjištění skutečnosti emailem obsahujícím všechny relevantní informace – kontakt viz Příloha 1. • Kongestivní selhání srdce stupně ≥ 2 • Prodloužení QT intervalu, stupně ≥ 2 • Synkopa libovolného stupně • Kognitivní poruchy stupně ≥ 3 • Potenciální polékové poškození jater včetně zvýšené ALT nebo AST v kombinaci se zvýšeným bilirubinem nebo klinickou žloutenkou podle kritérií Hyova pravidla: liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy’s law: o Treatment-emergent ALT or AST > 3 ULN in combination with total bilirubin > 2 ULN o Treatment-emergent ALT or AST > 3 ULN in combination with clinical jaundice • Suspected transmission of an infectious agent by the study drug, as defined below: Any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non- pathogenic, is considered an infectious agent. A transmission of an infectious agent may be suspected from clinical symptoms or laboratory findings that indicate an infection in a patient exposed to a medicinal product. This term applies only when a contamination of the study drug is suspected. o Zvýšení ALT nebo AST v souvislosti s léčbou > 3 x ULN v kombinaci s celkovým bilirubinem > 2 x ULN o Zvýšení ALT nebo AST v souvislosti s léčbou > 3 x ULN v kombinaci s klinickou žloutenkou • Podezření z přenosu infekčního agens prostřednictvím léč...
Sample 1
Adverse Events of Special Interest. There are no adverse events of special interest for this study.
Sample 1
Adverse Events of Special Interest. Selected nonserious and serious AEs will be reported as AESIs. The events must be reported on the AE eCRF within 24 hours of the study site personnel’s knowledge of the event. AESIs that also meet the definition of an SAE must be reported as described in Section 10.3. Adverse events of clinical interest for this study include: • Potential major cardiac and cerebrovascular events, including death (or any event with fatal outcome), myocardial infarction, cerebrovascular accident, hospitalization for unstable angina or chest pain, hospitalization for heart failure, and coronary revascularization/angioplasty/stent • Hypertension, defined as follows: - -‌ - • AEs consistent with orthostatic hypotension as confirmed by orthostatic xxxxx xxxxx • AEs suggestive of cystitis or urinary tract infection (UTI) - - - • Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value requiring that study drug be temporarily withheld or permanently discontinued (see Sections 8.4.7.1 and 8.4.7.2). To date, no concern regarding drug-induced liver toxicity has been identified; however, the Sponsor is monitoring laboratory data for a potential safety signal, consistent with Food and Drug Administration (FDA) guidance [FDA Guidance, 2009]. Serious AESIs and elevated liver enzymes or bilirubin requiring withholding of study drug must be reported within 24 hours of the study site personnel’s knowledge of the event by marking the appropriate box on the AE eCRF and assigning the most appropriate category. Additional information should be provided as directed in the eCRF Completion Guidelines. AESIs that also meet the definition of an SAE must be reported as an SAE, as described in Section 8.4.4. Nonserious AESIs should be reported within 72 hours of the site personnel’s knowledge, using the AE eCRF. 8.4.7.1. Criteria for Temporary Withholding of Study Drug in Association with Liver Test Abnormalities 8.4.7.2. Criteria for Permanent Discontinuation of Study Drug in Association with Liver Test Abnormalities
Sample 1
Adverse Events of Special Interest.  Grade ≥ 2 Congestive Heart Failure  Grade ≥ 2 QT prolongation  Any grade syncope  Grade ≥ 3 cognitive přípravku v zaměstnání, spojené či bez spojení s výskytem nežádoucí příhody, o Pokud není jinak určeno v protokolu, informace o podezření na přenos infekčního agens prostřednictvím přípravku /STIAMP/. Poznámka: takové informace jsou vždy považovány za nežádoucí příhodu, o Lékové interakce, včetně interakcí lék/potravina, lék/zdravotnický prostředek a lék/alkohol. Poznámka: takové informace jsou vždy považovány za nežádoucí příhodu.  Stížnosti na produkt (spojené nebo bez spojení s výskytem nežádoucí příhody). Lékař zašle společnosti Roche všechna nezávažná ADR jednou za měsíc. Pro schválené léčivé přípravky bude Lékař sbírat všechny AE a specifické okolnosti vypsané výše (spojené nebo bez spojení s nežádoucí příhodou) a bude je předávat společnosti Roche do jednoho (1) pracovního dne od zjištění skutečnosti emailem obsahujícím všechny relevantní informace – kontakt disturbances  Any grade fractures  Cases of potential drug- induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy’s law: o Treatment- emergent ALT or AST > 3 ULN in combination with total bilirubin > 2 ULN o Treatment- emergent ALT or AST > 3 ULN in combination with clinical jaundice  Suspected transmission of an infectious agent by the study drug, as defined below: Any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non- pathogenic, is considered an infectious agent. A transmission of an infectious agent may be suspected from clinical symptoms or laboratory findings that indicate an infection in a patient exposed to a medicinal product. This term applies only when a contamination of the study drug is suspected. viz Příloha 1.  Kongestivní selhání srdce stupně ≥ 2  Prodloužení QT intervalu, stupně ≥ 2  Synkopa libovolného stupně  Kognitivní poruchy stupně ≥ 3  Potenciální polékové poškození jater včetně zvýšené ALT nebo AST v kombinaci se zvýšeným bilirubinem nebo klinickou žloutenkou podle kritérií Hyova pravidla: o Zvýšení ALT nebo AST v souvislosti s léčbou > 3 x ULN v kombinaci s celkovým bilirubinem > 2 x ULN o Zvýšení ALT nebo AST v souvislosti s léčbou > 3 x ULN v kombinaci s klinickou žloutenkou  Podezření z přenosu infekčního agens prostřednictvím léčivého přípravku (STIAMP) definované takto: Za infekč...
Sample 1
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Related to Adverse Events of Special Interest

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Additional Events of Default Section 4.1 For purposes of this Supplemental Indenture and the Notes, in addition to the Events of Default set forth in Section 501 of the Indenture, each of the following also shall constitute an “Event of Default:” (a) default in the payment of the principal of or any premium on the Notes at Maturity; (b) there shall occur a default under any bond, debenture, note or other evidence of indebtedness of the Company, or under any mortgage, indenture or other instrument of the Company (including a default with respect to Securities of any series other than that series) under which there may be issued or by which there may be secured any indebtedness of the Company (or by any Subsidiary, the repayment of which the Company has guaranteed or for which the Company is directly responsible or liable as obligor or guarantor), whether such indebtedness now exists or shall hereafter be created, which default shall constitute a failure to pay an aggregate principal amount exceeding $10,000,000 of such indebtedness when due and payable after the expiration of any applicable grace period with respect thereto and shall have resulted in such indebtedness in an aggregate principal amount exceeding $10,000,000 becoming or being declared due and payable prior to the date on which it would otherwise have become due and payable, without such indebtedness having been discharged, or such acceleration having been rescinded or annulled, within a period of 10 days after there shall have been given, by first class mail, to the Company by the Trustee or to the Company and the Trustee by the Holders of at least a majority in principal amount of the Outstanding Notes a written notice specifying such default and requiring the Company to cause such indebtedness to be discharged or cause such acceleration to be rescinded or annulled and stating that such notice is a “Notice of Default” under the Indenture; and (c) the entry by a court of competent jurisdiction of one or more judgments, orders or decrees against the Company or any of its Subsidiaries in an aggregate amount (excluding amounts covered by insurance) in excess of $10,000,000 and such judgments, orders or decrees remain undischarged, unstayed and unsatisfied in an aggregate amount (excluding amounts covered by insurance) in excess of $10,000,000 for a period of 30 consecutive days. Section 4.2 Notwithstanding any provisions to the contrary in the Indenture, upon the acceleration of the Notes in accordance with Section 502 of the Indenture, the amount immediately due and payable in respect of the Notes shall equal the Outstanding principal amount thereof, plus accrued and unpaid interest, plus the Make-Whole Amount.

  • Listing of Events of Default Each of the following events or occurrences described in this Section 8.1 shall constitute an "Event of Default".

  • Material Changes; Undisclosed Events, Liabilities or Developments Since the date of the latest audited financial statements included within the SEC Reports, except as set forth on Schedule 3.1(i), (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock and (v) the Company has not issued any equity securities to any officer, director or Affiliate, except pursuant to existing Company stock option plans. The Company does not have pending before the Commission any request for confidential treatment of information. Except for the issuance of the Securities contemplated by this Agreement or as set forth on Schedule 3.1(i), no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur or exist with respect to the Company or its Subsidiaries or their respective businesses, prospects, properties, operations, assets or financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this representation is made or deemed made that has not been publicly disclosed at least 1 Trading Day prior to the date that this representation is made.

  • EDD Independent Subrecipient Reporting Requirements Effective January 1, 2001, the County of Orange is required to file in accordance with subdivision (a) of Section 6041A of the Internal Revenue Code for services received from a “service provider” to whom the County pays $600 or more or with whom the County enters into a contract for $600 or more within a single calendar year. The purpose of this reporting requirement is to increase child support collection by helping to locate parents who are delinquent in their child support obligations. The term “service provider” is defined in California Unemployment Insurance Code Section 1088.8, Subparagraph B.2 as “an individual who is not an employee of the service recipient for California purposes and who received compensation or executes a contract for services performed for that service recipient within or without the State.” The term is further defined by the California Employment Development Department to refer specifically to independent Subrecipients. An independent Subrecipient is defined as “an individual who is not an employee of the ... government entity for California purposes and who receives compensation or executes a contract for services performed for that ... government entity either in or outside of California.” The reporting requirement does not apply to corporations, general partnerships, limited liability partnerships, and limited liability companies. Additional information on this reporting requirement can be found at the California Employment Development Department web site located at xxxx://xxx.xxx.xx.xxx/Employer_Services.htm

  • Consequences of Events of Default (a) If an Event of Default of the type described in Section 3.1(a) or (b) has occurred and continued for 15 days or any other Event of Default has occurred, the interest rate on this Note will increase immediately by an increment of two percentage points to the extent permitted by law. Thereafter, until such time as no Event of Default exists, the interest rate on this Note will increase automatically at the end of each succeeding fiscal quarter by an additional increment of one percentage points to the extent permitted by law (but in no event will the interest rate exceed 18 percent per annum). Any increase of the interest rate resulting from the operation of this Section 3.2(a) will terminate as of the close of business on the date on which no Events of Default exist (subject to subsequent increases pursuant to this Section). (b) If an Event of Default of the type described in Section 3.1(d) has occurred, the principal amount of this Note (together with all accrued interest thereon and all other amounts payable in connection therewith) will become immediately due and payable without any action on the part of the Holder, and the Companies will immediately pay to the Holder all amounts due and payable with respect to this Note. (c) If an Event of Default of the type described in Section 3.1(a) or (b) has occurred and continued for 15 days and if an Event of Default of the type described in Section 3.1(b) has occurred and continued for 30 days, or any other Event of Default (other than under Section 3.1(d)) has occurred, the Holder may declare all or any portion of the outstanding principal amount of this Note (together with all accrued interest thereon and all other amounts due in connection therewith) due and payable and demand immediate payment of all or any portion of such amount. If the Holder demands immediate payment and all or any portion of the amounts due under this Note, the Companies will immediately pay to the Holder all amounts demanded to be paid with respect to this Note. (d) The Holder will also have any other rights which it may have been afforded under any contract or agreement at any time and any other rights which the Holder may have pursuant to applicable law. (e) Each Company hereby waives diligence, presentment, protest and demand and notice of protest and demand, dishonor and nonpayment of this Note, and expressly agrees that this Note, or any payment hereunder, may be extended from time to time and that the Holder may accept security for this Note or release security for this Note, all without in any way affecting the liability of the Companies hereunder.

  • Notification of Defaults and Events of Default Each Lender hereby agrees that, upon learning of the existence of a Default or an Event of Default, it shall promptly notify the Administrative Agent thereof. The Administrative Agent hereby agrees that upon receipt of any notice under this §14.10 it shall promptly notify the other Lenders of the existence of such Default or Event of Default.

  • Additional Accounting Services Ultimus shall also perform the following additional accounting services for each Portfolio: (i) Provide monthly (or as frequently as may reasonably be requested by the Trust or a Portfolio's investment adviser) a set of financial statements for each Portfolio as described below, upon request of the Trust: Statement of Assets and Liabilities Statement of Operations Statement of Changes in Net Assets Security Purchases and Sales Journals Portfolio Holdings Reports (ii) Provide accounting information for the following: (A) federal and state income tax returns and federal excise tax returns; (B) the Trust's semi-annual reports with the SEC on Form N-SAR; (C) the Trust's annual, semi-annual and quarterly (if any) shareholder reports; (D) registration statements on Form N-1A and other filings relating to the registration of shares; (E) Ultimus' monitoring of the Trust's status as a regulated investment company under Subchapter M of the Internal Revenue Code, as amended; (F) annual audit by the Trust's auditors; and (G) examinations performed by the SEC.

  • Representations True; No Event of Default Each of the representations and warranties of any of the Borrower and its Subsidiaries contained in this Credit Agreement, the other Loan Documents or in any document or instrument delivered pursuant to or in connection with this Credit Agreement shall be true as of the date as of which they were made and shall also be true at and as of the time of the making of such Loan or the issuance, extension or renewal of such Letter of Credit, with the same effect as if made at and as of that time (except to the extent of changes resulting from transactions contemplated or permitted by this Credit Agreement and the other Loan Documents and changes occurring in the ordinary course of business that singly or in the aggregate are not materially adverse, and to the extent that such representations and warranties relate expressly to an earlier date) and no Default or Event of Default shall have occurred and be continuing.

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