DOCUMENTATION OF ADVERSE EVENTS Sample Clauses

DOCUMENTATION OF ADVERSE EVENTS. Adverse events which occur during the induction therapy consisting of non-investigational treatment regimens do not need to be reported. All adverse events and serious adverse events will be monitored and reported in all patients (vaccination cohort and observation cohort). In this trial it was decided to define the AE observation period from randomization to the second follow up visit (6 months after randomization) for the following reasons. The investigational treatment is a vaccine and therefore is expected to act much longer in the patients organism than a small molecule. The vaccine can not be detected in the circulation by standard methods of pharmacokinetics, however, toxicity relating to the administered vaccine has to be monitored. From humoral response studies it is well known that all patients receiving BEC2/BCG vaccination will develop anti-BEC2-antibodies (= human anti murine antibodies [HAMA]) of the IgG-class within 6 [LOGO] The SILVX xxxdy -------------------------------------------------------------------------------- weeks after vaccination at the latest. When high titters of HAMA are established there is rapid clearance of any protein molecule of murine origin. Thus, it has to be assumed that no BEC2 will be present in the patient after the establishment of HAMA, since it will be rapidly cleared. As a consequence, monitoring and reporting of all adverse events and all serious adverse events will be performed until 6 months after randomization. Any AE that occurs in the course of clinical study, must principally be monitored and followed until: - it has receded - pathological laboratory findings have returned to normal - steady state has been achieved or - it has been shown to be unrelated to the study medication
Sample 1
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Related to DOCUMENTATION OF ADVERSE EVENTS

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

  • No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.

  • 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.

  • Absence of Adverse Changes From the date hereof until the Closing, there will have been no material adverse change in the financial or business condition of the Company.

  • Statement of Additional Information We shall provide you with a copy of the Trust’s current statement of additional information, including any amendments or supplements to it (“SAI), in a form suitable for reproduction , but we will not pay Printing Expenses or other expenses with respect to the SAI.

  • Notice of Adverse Change The Company shall promptly give notice to all holders of any Securities (but in any event within seven (7) days) after becoming aware of the existence of any condition or event which constitutes, or the occurrence of, any of the following:

  • No Adverse Interpretation of Other Agreements This Indenture may not be used to interpret any other indenture, loan or debt agreement of the Company or its Subsidiaries or of any other Person. Any such indenture, loan or debt agreement may not be used to interpret this Indenture.

  • 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.

  • RELEASE OF BID EVALUATION MATERIALS Requests concerning the evaluation of Bids may be submitted under the Freedom of Information Law. Information, other than statistical or factual tabulations or data such as the Bid Tabulation, shall only be released as required by law after Contract award. Bid Tabulations are not maintained for all procurements. Names of Bidders may be disclosed after Bid opening upon request. Written requests should be directed to the Commissioner.

  • DISCLOSURE OF TBS ACCESS CODE TO THIRD PARTY (a) The Account Holder must exercise all care to ensure that the TBS Access Code is not disclosed to any person and shall take all steps to prevent forgery or fraud in connection with the use of his TBS Access Code and/or the operation of the TBS. If the TBS Access Code is disclosed to any person, the Account Holder must forthwith give the Bank written notice thereof, thereupon the Account Holder shall immediately cease to use the TBS Access Code.

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