Benefit/Risk Assessment Sample Clauses

Benefit/Risk Assessment. Broad antitumor activity has been observed with selinexor treatment in preclinical and clinical studies. The information about selinexor’s mechanism of action and its efficacy observed in the KCP-330-027 study (NCT04256707) in patients with advanced or metastatic colorectal cancer (CRC), indicates that selinexor 80 mg once weekly with pembrolizumab 400 mg IV once every six weeks has activity in RAS mutated CRC; however, further investigation is warranted to elucidate clinical benefit. Adverse events in the study were consistent with those reported previously for selinexor and pembrolizumab administered separately with no clear overlapping toxicities. AEs noted during the trial include hematological, fatigue, nausea/diarrhea, low sodium/potassium attributed as possible/definite to either selinexor or pembrolizumab or possible with both treatments. In addition, selinexor is currently being evaluated in combination with other agents (targeted therapies and chemo-/radiotherapy). As these clinical trials proceed, more data will become available to assess both the added efficacy and possible adverse events resulting from these combinations to better inform potential trials combining selinexor with immune checkpoint blockade. In ongoing clinical studies, the most common non-hematologic AEs reported as related to selinexor have been predominantly nausea, vomiting, diarrhea, fatigue, anorexia and weight loss, and these AEs were assessed as low-grade and manageable with dose modification or supportive care. Hyponatremia (typically asymptomatic), confused state and dizziness have also been reported. On the other hand, hematological AEs including thrombocytopenia, neutropenia and anemia, which can be higher grade, were reported primarily in patients with hematologic malignancies. Any potential overlapping toxicity, such as thrombocytopenia, will be monitored closely by careful physical examination and clinical laboratory testing on Day 1 and Day 15 of Cycle 1 and Cycle 2 with dose adjustments as per prespecified dose modifications (see Table 4). A summary of the clinical trials, antitumor responses observed, and anticipated adverse events (AEs) of selinexor are found in the Investigator’s Brochure. Pembrolizumab is approved for use in the treatment of patients with unresectable or metastatic MSI-H or dMMR CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan as a result of an accelerated approval based upon the tumor response...
Sample 1
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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
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
Benefit/Risk Assessment. Detailed information about the known and expected benefits, risks, and reasonably expected adverse events (AEs) of ALXN1840 may be found in the IB. Information about the known or potential risks and benefits are detailed in the sections following. Dose-dependent elevations in transaminases (ALT and AST) Generally mild to moderate in severity, asymptomatic and reversible with dose adjustments were reported, usually after 3-6 weeks of treatment. Results obtained from studies of ALXN1840 and ammonium tetrathiomolybdate in patients with WD; see the IB Regular monitoring of liver function tests. Dose modification or discontinuation (Section 6.6) Anemia Anemia has been observed in patients with WD, attributed to overtreatment and resultant Cu depletion, see the IB Monitoring complete blood count. Dose modification or discontinuation (Section 6.6) Low white blood cell count (leukopenia, bone marrow toxicity) Leukopenia and bone marrow toxicity (myelosuppression) have been observed in patients with WD, attributed to overtreatment and resultant Cu depletion. Results obtained from studies of ALXN1840 and ammonium tetrathiomolybdate in patients with WD; see the IB Monitoring of complete blood count. Dose modification or discontinuation (Section 6.6) Neurological dysfunction Neurological worsening may occur due to Cu mobilization. Peripheral neuropathy may be seen with over-decoppering; however, symptoms such as myelosuppression is typically seen earlier Neurologic dysfunction is not anticipated in HV population. Risks associated with the study design and procedures Participants will undergo repeated blood draws to measure the PK of the study intervention and metabolism. Blood draws may result in ecchymosis, redness and minor pain to the site. On rare occasion, infection or thrombophlebitis can occur Blood draws are optimized for PK. A cannula may be placed to minimize needle sticks; however, a catheter may not be left in place for longer than 72 hours, and should be flushed a minimum of every 8 hours Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; Cu = copper; IB = Investigator’s Brochure; PK = pharmacokinetics; WD = Xxxxxx Disease.
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 - DST 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 Schedule 10.2 p.2 occurring and the impact of those threats upon DST organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”). b. Risk Mitigation - DST shall use commercially reasonable efforts to manage, control and remediate threats identified in the Risk Assessments that it believes are likely to result in material unauthorized access, copying, use, processing, disclosure, alteration, transfer, loss or destruction of Fund Data, consistent with the Objective, and commensurate with the sensitivity of the Fund Data and the complexity and scope of the activities of DST pursuant to the Agreement. c. Security Controls Testing - DST shall, on approximately an annual basis, engage an independent external party to conduct a review (including information security) of DST’s systems that are related to the provision of services. DST shall have a process to review and evaluate high risk findings resulting from this testing.

  • 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 – 6.1.1 The standards and procedures for evaluating the Employee’s performance; and 6.1.2 During the intervals for the evaluation of the Employee’s performance. 6.2 Despite the establishment of agreed intervals for evaluation, the Employer may in addition review the Employee’s performance at any stage while the contract of employment remains in force; 6.3 Personal growth and development needs identified during any performance review discussion must be documented in a Personal Development Plan as well as the actions agreed to and implementation must take place within set time frames; 6.4 The Employee’s performance will also be measured in terms of contributions to the goals and strategies set out in the Employer’s Integrated Development Plan (IDP) as described in 6.6 – 6.13 below; 6.5 The Employee will submit quarterly performance reports (SDBIP) and a comprehensive annual performance report at least one week prior to the performance assessment meetings to the Evaluation Panel Chairperson for distribution to the panel members for preparation purposes; 6.6 Assessment of the achievement of results as outlined in the performance plan: 6.6.1 Each KPI or group of KPIs shall be assessed according to the extent to which the specified standards or performance targets have been met (qualitative and quantitative) and with due regard to ad-hoc tasks that had to be performed under the KPI; 6.6.2 A rating on the five-point scale described in 6.9 below shall be provided for each KPI or group of KPIs which will then be multiplied by the weighting to calculate the final score; 6.6.3 The Employee will submit his self-evaluation to the Employer prior to the formal assessment; 6.6.4 In the instance where the employee could not perform due to reasons outside the control of the employer and employee, the KPI will not be considered during the evaluation. The employee should provide sufficient evidence in such instances; and 6.6.5 An overall score will be calculated based on the total of the individual scores calculated above.

  • 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.

  • Joint Assessment If the Premises are not separately assessed, Lessee's liability shall be an equitable proportion of the Real Property Taxes for all of the land and improvements included within the tax parcel assessed, such proportion to be conclusively determined by Lessor from the respective valuations assigned in the assessor's work sheets or such other information as may be reasonably available.

  • Diagnostic Assessment 6.3.1 Boards shall provide a list of pre-approved assessment tools consistent with their Board improvement plan for student achievement and which is compliant with Ministry of Education PPM (PPM 155: Diagnostic Assessment in Support of Student Learning, date of issue January 7, 2013). 6.3.2 Teachers shall use their professional judgment to determine which assessment and/or evaluation tool(s) from the Board list of preapproved assessment tools is applicable, for which student(s), as well as the frequency and timing of the tool. In order to inform their instruction, teachers must utilize diagnostic assessment during the school year.

  • Conformity Assessment Procedures 1. Each Party shall give positive consideration to accepting the results of conformity assessment procedures of other Parties, even where those procedures differ from its own, provided it is satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to its own procedures. 2. Each Party shall seek to enhance the acceptance of the results of conformity assessment procedures conducted in the territories of other Parties with a view to increasing efficiency, avoiding duplication and ensuring cost effectiveness of the conformity assessments. In this regard, each Party may choose, depending on the situation of the Party and the specific sectors involved, a broad range of approaches. These may include but are not limited to: (a) recognition by a Party of the results of conformity assessments performed in the territory of another Party; (b) recognition of co-operative arrangements between accreditation bodies in the territories of the Parties; (c) mutual recognition of conformity assessment procedures conducted by bodies located in the territory of each Party; (d) accreditation of conformity assessment bodies in the territory of another Party; (e) use of existing regional and international multilateral recognition agreements and arrangements; (f) designating conformity assessment bodies located in the territory of another Party to perform conformity assessment; and (g) suppliers’ declaration of conformity. 3. Each Party shall exchange information with other Parties on its experience in the development and application of the approaches in Paragraph 2(a) to (g) and other appropriate approaches with a view to facilitating the acceptance of the results of conformity assessment procedures. 4. A Party shall, upon request of another Party, explain its reasons for not accepting the results of any conformity assessment procedure performed in the territory of that other Party.

  • 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:

  • Needs Assessment The determination of whether the Annual Income of a family or individual occupying or seeking to occupy a Qualifying Unit complies with the requirements for Extremely Low-Income Households or Low- to Moderate-Income Households shall be made by the applicable housing authority in the CDBG-DR Program area prior to admission of such family or individual to occupancy of a Qualifying Unit.

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