Analysis of Safety Endpoints Sample Clauses

Analysis of Safety Endpoints. ‌ All reported SAEs and AEs will be coded using MedDRA and grouped by body system. SAEs and AEs will be tabulated by treatment group using standard coding terms sorted by body system. The incidence of AEs in each treatment arm will be tabulated by seriousness, severity, and relationship to study drug. If an AE is reported more than once during the study period for a given subject, the greatest severity and the worst-case relationship will be presented in tables. The number of SAEs and AEs will be summarized for each treatment group as follows: (i) The proportion of subjects with at least one (S)AE, (ii) The average number of (S)AEs per patient, and (iii) The rate of (S)AEs per patient week of follow-up. Histograms showing the frequency of the number of (S)AEs in each treatment group will be included. Rates of (S)AEs by System Organ Class (SOC) will be presented by treatment group. Poisson regression modeling will be used to derive rate ratios and 95% CIs for each SOC. The rate ratios will be compared using a two-sided 0.05 level test for Poisson count data. Safety lab data at each study visit and changes from baseline will be summarized by treatment group. In addition, the following clinical laboratory summaries will be presented by treatment group: (i) the incidence of clinically significant abnormalities at each study visit; and (ii) tables summarizing the frequencies of subjects below, within, and above the normal reference ranges at baseline and end of study; and (iii) tables displaying baseline to end of study shifts in each laboratory value (shifts between below, within or above normal range). The proportion of subjects permanently discontinuing study drug will be tabulated by treatment group. Drug discontinuation events will be categorized as: (1) Permanently discontinued study drug and (2) Permanently discontinued study drug and withdrew from study. The reason for permanent drug discontinuation will be summarized. The number of hospitalization events and proportion of subjects hospitalized from baseline to Day 56 will be summarized and compared by treatment group. Poisson regression modeling will be used to derive rate ratios and 95% CIs to compare hospitalization rates between treatment groups.
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Analysis of Safety Endpoints. ‌ All reported treatment emergent SAEs and AEs will be coded using MedDRA and grouped by body system. Treatment emergent AEs are defined as AEs presenting post study treatment initiation. SAEs and AEs will be tabulated by treatment group using standard coding terms sorted by body system. The incidence of AEs in each treatment arm will be tabulated by severity. The number of SAEs and AEs will be summarized for each treatment group as follows: (i) The proportion of subjects with at least one (S)AE, (ii) The average number of (S)AEs per patient, and (iii) The rate of (S)AEs per patient week of follow-up. Histograms showing the frequency of the number of (S)AEs in each treatment group will be included. Rates of (S)AEs by System Organ Class (SOC) will be presented by treatment group. Poisson regression modeling will be used to derive rate ratios and 95% CIs comparing overall S(AE) rates by treatment group as well as within each SOC. The rate ratios will be compared using a two-sided 0.05 level test for Poisson count data. Safety lab data at Visit 2 and Visit 4 and changes from baseline will be summarized by treatment group. In addition, the following clinical laboratory summaries will be presented by treatment group: (i) the incidence of clinically significant abnormalities at each study visit; and (ii) tables summarizing the frequencies of subjects below, within, and above the normal reference ranges at baseline and end of study; and (iii) tables displaying baseline to end of study shifts in each laboratory value (shifts between below, within or above normal range).

Related to Analysis of Safety Endpoints

  • Risk Analysis The Custodian will provide the Fund with a Risk Analysis with respect to Securities Depositories operating in the countries listed in Appendix B. If the Custodian is unable to provide a Risk Analysis with respect to a particular Securities Depository, it will notify the Fund. If a new Securities Depository commences operation in one of the Appendix B countries, the Custodian will provide the Fund with a Risk Analysis in a reasonably practicable time after such Securities Depository becomes operational. If a new country is added to Appendix B, the Custodian will provide the Fund with a Risk Analysis with respect to each Securities Depository in that country within a reasonably practicable time after the addition of the country to Appendix B.

  • Sampling and Analysis The Seller has sole responsibility for quality control of the coal and shall forward its “as loaded” quality to the Buyer as soon as possible. The sampling and analysis of the coal delivered hereunder shall be performed by Buyer and the results thereof shall be accepted and used for the quality and characteristics of the coal delivered under this Agreement. All analyses shall be made in Buyer’s laboratory at Buyer’s expense in accordance with ASTM standards where applicable, or using standards mutually acceptable to both parties. Samples for analyses shall be taken by any ASTM standards or standards mutually acceptable to both parties, and may be composited and shall be taken with a frequency and regularity sufficient to provide reasonably accurate representative samples of the deliveries made hereunder. Seller represents that it is familiar with Buyer’s sampling and analysis practices, and finds them to be acceptable. Buyer shall notify Seller in writing of any significant changes in Buyer’s sampling and analysis practices. Any such changes in Buyer’s sampling and analysis practices shall, except for ASTM or mutually agreeable changes in practices, provide for no less accuracy than the sampling and analysis practices existing at the time of the execution of this Agreement, unless the Parties otherwise mutually agree. (1) part shall be used for analysis by Buyer; one (l) part shall be used by Buyer as a check sample, if Buyer in its sole judgment determines it is necessary; one (1) part shall be retained by Buyer (LG&E) until the twenty-fifth (25th) of the month following the month of unloading (the “LG&E Disposal Date”) or Buyer (KU) until thirty (30) days after the sample is taken (the “KU Disposal Date”), the LG&E Disposal Date and the KU Disposal Date are collectively the “Disposal Date”), and shall be delivered to Seller for analysis if Seller so requests before the Disposal Date; and one part (“Referee Sample”) shall be retained by Buyer until the Disposal Date. Seller shall be given copies of all analyses made by Buyer by the tenth (10th) business day of the month following the month of unloading. Seller, on reasonable notice to Buyer shall have the right to have a representative present to observe the sampling and analyses performed by Buyer. Unless Seller requests a Referee Sample analysis before the Disposal Date, Buyer’s analysis shall be used to determine the quality of the coal delivered hereunder. The Monthly Weighted Averages shall be determined by utilizing the individual shipment analyses. If any dispute arises before the Disposal Date, the Referee Sample retained by Buyer shall be submitted for analysis to an independent commercial testing laboratory (“Independent Lab”) mutually chosen by Buyer and Seller. For each coal quality specification in question, a dispute shall be deemed not to exist and Buyer’s analysis shall prevail and the analysis of the Independent Lab shall be disregarded if the analysis of the Independent Lab differs from the analysis of Buyer by an amount equal to or less than: (i) 0.50% moisture (ii) 0.50% ash on a dry basis (iii) 100 Btu/lb. on a dry basis (iv) 0.10% sulfur on a dry basis. For each coal quality specification in question, if the analysis of the Independent Lab differs from the analysis of Buyer by an amount more than the amounts listed above, then the analysis of the Independent Lab shall prevail and Buyer’s analysis shall be disregarded. The cost of the analysis made by the Independent Lab shall be borne by Seller to the extent that Buyer’s analysis prevails and by Buyer to the extent that the analysis of the Independent Lab prevails.

  • CONTRACT WORK HOURS AND SAFETY STANDARDS As per the Contract Work Hours and Safety Standards Act (40 U.S.C. 3701-3708), where applicable, all Customer Purchase Orders in excess of ,000 that involve the employment of mechanics or laborers must include a provision for compliance with 40 U.S.C. 3702 and 3704, as supplemented by Department of Labor regulations (29 CFR Part 5). Under 40 U.S.C. 3702 of the Act, each contractor must be required to compute the wages of every mechanic and laborer on the basis of a standard work week of 40 hours. Work in excess of the standard work week is permissible provided that the worker is compensated at a rate of not less than one and a half times the basic rate of pay for all hours worked in excess of 40 hours in the work week. The requirements of 40 U.S.C. 3704 are applicable to construction work and provide that no laborer or mechanic must be required to work in surroundings or under working conditions which are unsanitary, hazardous or dangerous. These requirements do not apply to the purchases of supplies or materials or articles ordinarily available on the open market, or contracts for transportation or transmission of intelligence.

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • Health and Safety Plan Consultant shall prepare and submit a Health and Safety Plan (“HASP”) for the portion of Consultant’s work that will involve field work, assessments, or investigations of certain Project elements. The HASP shall describe how Consultant plans to complete field work, assessments, and/or investigations at the RWF. Consultant’s HASP must comply with the CIP HASP and shall be updated as new conditions are encountered.

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall: (a) supervise all aspects of the operations of the Funds; (b) obtain and evaluate pertinent information about significant developments and economic, statistical and financial data, domestic, foreign or otherwise, whether affecting the economy generally or the Funds, and whether concerning the individual issuers whose securities are included in the assets of the Funds or the activities in which such issuers engage, or with respect to securities which the Advisor considers desirable for inclusion in the Funds' assets; (c) determine which issuers and securities shall be represented in the Funds' investment portfolios and regularly report thereon to the Board of Trustees; (d) formulate and implement continuing programs for the purchases and sales of the securities of such issuers and regularly report thereon to the Board of Trustees; and (e) take, on behalf of the Trust and the Funds, all actions which appear to the Trust and the Funds necessary to carry into effect such purchase and sale programs and supervisory functions as aforesaid, including but not limited to the placing of orders for the purchase and sale of securities for the Funds.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Medical Verification The Town may require medical verification of an employee’s absence if the Town perceives the employee is abusing sick leave or has used an excessive amount of sick leave. The Town may require medical verification of an employee’s absence to verify that the employee is able to return to work with or without restrictions.

  • Prescription Safety Glasses Prescription safety glasses will be furnished by the employer. The employer retains the authority to establish reasonable rules and procedures regarding frequency of issue, replacement of damaged glasses, limits on reimbursement costs and coordination with the employer's vision plan.

  • HEALTH, SAFETY AND ENVIRONMENT In the performance of this Contract, Contractor and Operator shall conduct Petroleum Operations with due regard to health, safety and the protection of the environment (“HSE”) and the conservation of natural resources, and shall in particular:

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