Solicited Adverse Events Sample Clauses

Solicited Adverse Events. With the exception of the Day 7 (+3 days) in-clinic assessment for participants in the immunogenicity cohort, the severity of solicited adverse events will be made by the participant. Severity will be assigned using the definitions in Appendix 3.
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Solicited Adverse Events. Solicited adverse events are events the participant is specifically asked about. These adverse events are commonly observed soon after receipt of vaccines and relate to local and systemic signs and symptoms. Solicited adverse events will be collected for 7 days post-vaccination1. These will be recorded daily in the eDiary for all participants. Participants in the immunogenicity cohort will also have an in-clinic assessment on Day 7 (+3 days). Solicited adverse events will also be reviewed during the telephone calls on Day 1 (+2 days) (all participants) and Day 7 (+3 days) (main cohort only). For this study, solicited adverse events to be collected include: • Vaccination site reactions: pain, induration, warmth, erythema (redness) • Systemic adverse events: feverishness, chills, myalgia, fatigue, headache, nausea, arthralgia, malaise 1 In the event that they persist longer than 7 days then an adverse event will be recorded Participants will be asked to record the presence of these symptoms and grade the severity as described in Section 5.3.1. Oral temperature will be measured using the thermometer provided and the diameter of induration will be measured with the tape measure provided.
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Related to Solicited Adverse Events

  • 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.

  • No Material Adverse Event Since the respective dates as of which information is disclosed in the Registration Statement, the Prospectus and the Incorporated Documents, except as otherwise stated therein, there shall not have been (i) any change or decrease in previously reported results specified in the letter or letters referred to in paragraph (d) of this Section 6 or (ii) any change, or any development involving a prospective change, in or affecting the condition (financial or otherwise), earnings, business or properties of the Company and its subsidiaries taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated in the Registration Statement, the Prospectus and the Incorporated Documents (exclusive of any amendment or supplement thereto) the effect of which, in any case referred to in clause (i) or (ii) above, is, in the sole judgment of the Manager, so material and adverse as to make it impractical or inadvisable to proceed with the offering or delivery of the Shares as contemplated by the Registration Statement (exclusive of any amendment thereof), the Incorporated Documents and the Prospectus (exclusive of any amendment or supplement thereto).

  • 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.

  • 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.

  • Notice of Material Adverse Change Firm agrees to notify Citizens in writing of any “Material Adverse Change” to Firm within ten (10) days of said change. A “Material Adverse Change” means: (i) a change in the business operations or financial condition of Firm which negatively impacts its capacity to meet its professional or financial obligations;