Safety Endpoints Sample Clauses

Safety Endpoints. Safety endpoints are listed below. • Rates of ocular adverse events, including SSIs related to the optical properties for either eye • Adverse events • Device deficiencies • IOL observations • Subjective PCO • Posterior Capsulotomies 9.1 Outline of Clinical Trial
Sample 1
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Safety Endpoints. Safety parameters to be collected and assessed: - Incidence, severity, causality and outcomes of Adverse Events (serious and non-serious), with particular attention being paid to infections - Evolution of laboratory parameters such as complete blood cell count (CBC), with a focus on red cells (haemoglobin), neutrophils and platelets, liver tests, renal function tests and coagulation - Number of patients withdrawn for safety issues • Other parameters: - Level (if any) of circulating antibodies against NI-0501 to determine immunogenicity (ADA) Statistical Analysis: • The primary endpoint Overall Response Rate will be evaluated using the exact binomial test at the one-sided 0.025 level. • Time to Response, durability of Response and Survival time will be presented using Xxxxxx-Xxxxx curves with medians calculated if available. 95% confidence intervals will be calculated for the median for each of these endpoints. • Additional endpoints based on binary outcomes including number of patients who reduce glucocorticoids by 50% or more, and number of patients able to proceed to HSCT will be converted to proportions and associated 95% confidence intervals calculated. • Statistical significance in terms of p-values will only be obtained for the primary endpoint. All other endpoints will be viewed as supportive for the primary endpoint and as a consequence no formal hierarchy of endpoints will be declared.
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Safety Endpoints. Safety and tolerability of multiple IV infusions of NI-0501 will be assessed as follows: • Incidence, severity, causality and outcomes of AEs (serious and non-serious), with particular attention being paid to infections • Evolution of laboratory parameters such as complete blood cell count (CBC), with focus on red cells (haemoglobin), neutrophils and platelets, liver tests, renal function tests and coagulation • Number of patients withdrawn for safety issues
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Safety Endpoints. Frequency, intensity, and relationship to study drug of AEs and SAEs, and change from baseline in the following assessments: vital sign measurements, 12-lead ECGs, clinical laboratory measurements, and weight.
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Safety Endpoints. Safety will be assessed by an evaluation of adverse events, including eye symptoms (collected at each study visit); ***. All subjects will be screened for the *** using a validated survey instrument ***, and for *** using the ***. Follow-up *** assessments will be done at *** after ***.
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Safety Endpoints. Original text: Amended text:
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Safety Endpoints. ‌ Safety will be assessed by evaluation adverse events (AEs)/serious adverse events (SAEs); xxxxx xxxxx, laboratory parameters (screening, periodically during the study and end of study); electrocardiograms; physical examinations; cognitive function tests using the Cambridge Neuropsychological Test Automated Battery (CANTAB). All subjects will be screened for the presence and severity of depression using the PHQ-9: Modified for Teens (Appendix 4) and for suicidal/ideation using the Columbia Suicide Severity Rating Scale (C-SSRS) (Appendix 5: Sample Columbia Suicide Severity Rating Scale) and follow up assessments will be done at each visit after treatment has been initiated. Bone age (X-ray of the hand and wrist) will be evaluated at baseline and end of study or early termination. Effect on bone mineral density and bone mineral content, as evaluated by Dual-energy X-Ray Absorptiometry (DXA) will be performed at baseline, end of study or early termination, at selected sites.
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Safety Endpoints 
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Related to Safety Endpoints

  • Safety Boots Each employee, after 3 months’ continuous service, will be reimbursed (on production of a receipt), the cost of one pair of safety boots (approved by the employer), in each year, to a maximum of $110.00. All protective clothing such as wet weather jackets, safety helmets, welding jackets, welding xxxxxxx, welding gauntlets, rubber boots, etc, (which remain the property of the Company), will be supplied on all occasions deemed necessary.

  • Safety Glasses Section 1. The City shall supply prescription safety glasses with plastic lenses to employees who are required to wear safety glasses and who are members of the classifications contained in Appendix C to this contract. Safety glasses which are authorized must be industrial grade safety glasses which meet or exceed the requirements of ANSI Specification Z87. 1. All employees who are required to wear safety glasses shall also be required to wear side xxxxxxx, either permanent or snap-on, whenever an eye hazard exists. Solid tinted glasses will not be approved unless required by prescription. Photogray, progressive, scratch coating and/or anti-glare lenses may be considered for those employees who primarily work outdoors or as prescribed. In the event that additional classes are identified as needing either prescription safety glasses or protective eyewear, such classes may be added to the classification list in Appendix C upon approval of PAGE and the City. Section 2. The City agrees to pay the full cost of required prescription safety glasses, with frames not to exceed $75.00. This excludes the cost of the eye examination which will be the responsibility of the employee. The effected employees will be allowed one (1) replacement of safety glasses every two (2) years. In the event the safety glasses become lost, unserviceable, or broken on the job, the employee must present a written request for replacement to the Department Head and Human Resources Director. If the employee breaks his safety glasses while on the job, the Department shall replace the glasses at no cost to the employee. The replacement of lost glasses or glasses that are broken off the job will be at the discretion of the Department Head and Human Resources Director. If an employee has been provided safety glasses by the City, the employee shall be permitted to retain possession of the glasses after separation from the City without reimbursing the City for any costs associated with the glasses. Section 3. An employee who is required to wear prescription safety glasses must present a written request to his department head or designated representative. Section 4. The employee must obtain a current prescription and the employee is authorized the use of sick leave not to exceed two (2) hours to accomplish this examination. The employee will obtain a purchase order from the Department Head prior to ordering the safety glasses. The employee will present the purchase order to the appropriate vendor when ordering. The vendor will contact the appropriate Department Head when the glasses are ready for delivery. The Department Head will then notify the employee who will present himself at the vendor for fitting and pickup. Section 5. In the event a probationary employee has been issued safety glasses and terminates his employment with the City for any reason during the probationary period, he shall be required to reimburse the City for any expenses incurred in the purchase of safety glasses.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Safety Data Sheets If specified by City in the solicitation or otherwise required by this Contract, Contractor must send with each shipment one (1) copy of the Safety Data Sheet (SDS) for each item shipped. Failure to comply with this procedure will be cause for immediate termination of the Contract for violation of safety procedures.

  • Safety Program The Contractor shall design a specific safety program for the Work for the site(s). The Contractor shall establish and require all Subcontractors to establish reasonable safety programs. The Contractor shall also submit its standard monthly safety reports to the Owner and Design Professional. No imposition of responsibility on the Contractor for safety under this Contract shall relieve any subcontractor of its responsibility for safety of persons or property on or near the Project Site. The Contractor shall include in his plant he names of the person in charge of Safety.

  • 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.

  • Safety Where an employee is prevented from working at the employee’s particular function as a result of unsafe conditions caused by the inclement weather, the employee may be transferred to other work in the employee’s classification on site, until the unsafe conditions are rectified. Where such alternative is not available and until the unsafe conditions are rectified, the employee shall remain on site. The employee shall be paid for such time without reduction of the employees’ inclement weather entitlement.

  • MATERIAL SAFETY DATA SHEETS As applicable, Contractor shall provide Purchaser with all appropriate Material Safety Data Sheets (“MSDS”) at the time of delivery of each shipment of Goods which requires such compliance and/or and for materials used by Contractor while performing Services and any updates of the same.

  • Material Safety Data Sheet Seller shall provide to Buyer with each delivery any Material Safety Data Sheet applicable to the work in conformance with and containing such information as required by the Occupational Safety and Health Act of 1970 and regulations promulgated thereunder or its State approved counterpart.

  • Safety Footwear 1. The State will provide employees in the positions listed in Section 3 below, and employees who are currently required to wear safety footwear by Department Work Rules, an allowance of one hundred fifty dollars ($150.00) for replacement of safety footwear. This allowance will be paid to employees on a semiannual basis, with half paid in January and half paid in July to eligible employees on the payroll at the time of the payments. Employees of Departments with work rules that provide such safety footwear will not be eligible for the safety footwear allowance. 2. Safety footwear purchased must meet ANSI standards where applicable. Requirements for the wearing of safety footwear will be in accordance with work rules published by the State. 3. Positions required to wear safety footwear:

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