Benefit/Risk Assessment Sample Clauses

Benefit/Risk Assessment. More detailed information about the known and potential benefits and potential risks of RIST4721 may be found in the IB.
Sample 1
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Benefit/Risk Assessment. ‌ Blockade of XPO1 has shown anti-SARS-CoV2 activity in vitro and anti-viral effects in animal models as well as in influenza models. Severe influenza is associated with a pro-inflammatory cytokine profile similar to severe COVID-19. Based on preclinical studies, inhibition of XPO1 is anticipated to confer both anti-SARS-CoV2 and anti-inflammatory activity at relatively low doses of selinexor to be used in this study. Higher doses of selinexor (160 mg per week) approved for use in the treatment of advanced RRMM are associated with dose-dependent and generally reversible nausea, fatigue, emesis, anorexia, low sodium and thrombocytopenia. The lower doses of selinexor used here (60 mg per week) are expected to achieve the relevant pharmacological concentrations. There are no known clinically significant drug-drug interactions with selinexor. The protocol allows concurrent use of other investigational anti-viral and/or anti-inflammatory agents. The highly selective and potent oral XPO1 inhibitors verdinexor and selinexor have no pharmacologically important discernable differences. XPO1 inhibitors have activity in models of sepsis/ARDS, inflammation, and influenza. In a recent study selinexor demonstrated potent activity against SARS-CoV2 (IC50= ~10 nM). The adverse event profile of low dose selinexor consists of low grade, reversible and treatable symptoms (Appendix 2). Therefore, we believe that the opportunity to confer both anti-viral and anti-inflammatory activity with a novel agent targeting a host protein warrants provides a positive risk /benefit assessment in the treatment of severe COVID-19.
Sample 1

Related to Benefit/Risk Assessment

  • Risk Assessment An assessment of any risks inherent in the work requirements and actions to mitigate these risks.

  • Risk Assessments a. Risk Assessment - Transfer Agent shall, at least annually, perform risk assessments that are designed to identify material threats (both internal and external) against Fund Data, the likelihood of those threats occurring and the impact of those threats upon the Transfer Agent organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”).

  • Periodic Risk Assessment Provider further acknowledges and agrees to conduct periodic risk assessments and remediate any identified security and privacy vulnerabilities in a timely manner.

  • Performance Assessment 6.1 The Performance Plan (Annexure A) to this Agreement sets out key performance indicators and competencies that needs to be evaluated in terms of –

  • Data Protection Impact Assessment If, pursuant to Data Protection Law, Customer (or its Controllers) are required to perform a data protection impact assessment or prior consultation with a regulator, at Customer’s request, SAP will provide such documents as are generally available for the Cloud Service (for example, this DPA, the Agreement, audit reports or certifications). Any additional assistance shall be mutually agreed between the Parties.

  • Comprehensive Assessment an initial and ongoing part of the member-centered planning process employed by the interdisciplinary team (IDT) to identify the member’s outcomes and the services and supports needed to help support those outcomes. It includes an ongoing process of using the knowledge and expertise of the member and caregivers to collect information about:

  • Impact Assessment If Service Provider desires to make any change, upgrade, replacement or addition that may have an adverse impact or require changes as described in Section 9.6(c) or increase the risk of Service Provider not being able to provide the Services in accordance with this Agreement or violate or be inconsistent with DIR Standards or Strategic Plans, then Service Provider shall prepare a written risk assessment and mitigation plan (1) describing in detail the nature and extent of such adverse impact or risk, (2) describing any benefits, savings or risks to DIR or the DIR Customers associated with such change, and (3) proposing strategies to mitigate any adverse risks or impacts associated with such change and, after consultation and agreement with DIR, implement the plan.

  • Data Protection Impact Assessments Xxxx shall provide reasonable assistance to Client with any data protection impact assessments, and prior consultations with a Supervisory Authority, required under Data Protection Laws, in each case solely in relation to Processing of Personal Data by, and taking into account the nature of the Processing and information available to, Xxxx.

  • Criteria for Performance Assessment A. A teacher’s performance shall be assessed based on the criteria set forth in the evaluation instrument, Appendix D.

  • EQUIPMENT TAX ASSESSMENT 17.1 Any bid for public improvement shall comply with Nebraska Revised Statutes Section 77-1323 and 77-1324. Indicating; every person, partnership, limited liability company, association or corporation furnishing labor or material in the repair, alteration, improvement, erection, or construction of any public improvement shall sign a certified statement which will accompany the contract. The certified statement shall state that all equipment to be used on the project, except that acquired since the assessment date, has been assessed for taxation for the current year, giving the county where assessed.

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