Adverse Event Severity Sample Clauses

Adverse Event Severity. The term “severe” is used to describe the intensity of an AE; the event itself could be of relatively minor clinical significance (e.g., “severe” headache). This is not the same as a “serious” AE. The severity of the AE will be graded by the Investigator according to the NCI CTCAE Grading Scale, v5.0 (the NCI CTCAE files can be accessed online at the following URL: xxxx://xxx.xxx.xxx.xxx/ftp1/CTCAE/About.html). Events that are not specifically defined in CTCAE v5.0 should be assessed according to the guidance provided on page 2 of the CTCAE v5.0 document
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Adverse Event Severity. The term “severe” is used to describe the intensity of an AE; the event itself could be of relatively minor clinical significance (e.g., ‘severe’ headache). This is not the same as a “serious” AE. The severity of the AE will be graded by the Investigator according to the NCI CTCAE Grading Scale, v. 5.0 (the NCI CTCAE files can be accessed online at the following URL: xxxx://xxx.xxx.xxx.xxx/ftp1/CTCAE/About.html). If there is not a specific NCI CTCAE grading scale for an AE, the severity will be characterized as mild, moderate, severe, or life-threatening, according to the following definitions: • Grade 1 (mild) events are usually transient in nature and do not interfere with the patient’s daily activities. • Grade 2 (moderate) events introduce a low level of inconvenience or concern to the patient and may interfere with daily activities. • Grade 3 (severe) events interrupt the patient’s usual daily activities. • Grade 4 events are those that are considered to be life-threatening.

Related to Adverse Event Severity

  • 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.

  • 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.

  • Reasonable Suspicion Testing All Employees Performing Safety-Sensitive Functions A. Reasonable suspicion testing for alcohol or controlled substances may be directed by the Employer for any employee performing safety-sensitive functions when there is reason to suspect that alcohol or controlled substance use may be adversely affecting the employee’s job performance or that the employee may present a danger to the physical safety of the employee or another. B. Specific objective grounds must be stated in writing that support the reasonable suspicion. Examples of specific objective grounds include but are not limited to: 1. Physical symptoms consistent with alcohol and/or controlled substance use; 2. Evidence or observation of alcohol or controlled substance use, possession, sale, or delivery; or 3. The occurrence of an accident(s) where a trained manager, supervisor or lead worker suspects alcohol or other controlled substance use may have been a factor.

  • Loss Assessment We will pay up to $1000 for your share of loss assessment charged during the policy period against you by a corporation or as- sociation of property owners, when the assess- ment is made as a result of:

  • 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.

  • Independence from Material Breach Determination Except as set forth in Section X.D.1.c, these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard for OIG’s decision that Xxxxx has materially breached this IA, which decision shall be made at OIG’s discretion and shall be governed by the provisions in Section X.D, below.

  • Information About Your Right to Dispute Errors In case of errors or questions about your electronic transactions, call (000) 000-0000, contact Oxygen Support via the in-app messaging feature or send an email message to: xxxxxx@xxxxxxxxx.xxx as soon as you can, if you think your statement or receipt is wrong or if you need more information about a transaction listed on the statement or receipt. We must hear from you no later than 60 days after we sent the FIRST statement on which the problem or error appeared. You will need to tell us: 1. Your name, the Account number and/or 16-digit Card number; 2. Describe the error or the transfer you are unsure about, and explain why you believe there is an error or why you need more information: and 3. The dollar amount of the suspected error. If you provide this information orally, we may require that you send your complaint or question in writing within ten (10) business days. We will determine whether an error occurred within ten (10) business days after we hear from you and will correct any error promptly. If we need more time, however, we may take up to forty-five (45) days to investigate your complaint or question. If we decide to do this, we will credit your Account within ten (10) business days for the amount you think is in error, so that you will have use of the money during the time it takes to complete the investigation. If we ask you to put your complaint or question in writing and you do not provide it within ten (10) business days, we may not credit your Account. For errors involving a new Account, POS transactions, or foreign-initiated transactions, we may take up to ninety (90) days to investigate your complaint or question. For a new Account, we may take up to twenty

  • Reporting of Non-Force Majeure Events Each Party (the “Notifying Party”) shall notify the other Parties when the Notifying Party becomes aware of its inability to comply with the provisions of this Agreement for a reason other than a Force Majeure event. The Parties agree to cooperate with each other and provide necessary information regarding such inability to comply, including the date, duration, reason for the inability to comply, and corrective actions taken or planned to be taken with respect to such inability to comply. Notwithstanding the foregoing, notification, cooperation or information provided under this Article shall not entitle the Party receiving such notification to allege a cause for anticipatory breach of this Agreement.

  • ESCALATION PROCEDURES 48.1 The Standard Practices outlines the escalation process which may be invoked at any point in the Service Ordering, Provisioning, and Maintenance processes to facilitate rapid and timely resolution of disputes.

  • Meteorological Data Reporting Requirement (Applicable to wind generation facilities only)

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