Safety Endpoints Sample Clauses

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 ***.
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cells (haemoglobin), neutrophils and platelets, liver tests, renal function tests and coagulation - Number of patients withdrawn for safety issues • Other parameters: - Level (if any) of circulating antibodies against NI-0501 to determine immunogenicity (ADA) Statistical Analysis: • The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. CONTENTS INVESTIGATOR AGREEMENT 2 CONTACT LIST 3 NI-0501-04 SYNOPSIS 4
Sample 1
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cells (haemoglobin), neutrophils and platelets, liver tests, renal function tests and coagulation • Number of patients withdrawn for safety issues
Sample 1
Safety Endpoints. The safety profile of RP103 will be investigated by safety reviews conducted by the Investigator at or prior to each Monthly or Quarterly visit and through adverse event report monitoring (including attribution of treatment-emergent adverse events and serious adverse events [SAEs]), physical examination (including basic neurological and skin assessment findings), xxxxx xxxxx, ECG and clinical laboratory testing as outlined in the Schedule of Events (Appendix 14.1).
Sample 1
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 INVESTIGATIONAL PLAN
Sample 1
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.
Sample 1
Safety Endpoints. Original text: These will include adverse events reported while on study drug. Amended text: Safety endpoints will include: • Adverse events reported while on study drug • Skeletal assessments (selected US sites) • Ophthalmic assessments (selected US sites) • Pharmacokinetic/Pharmacodynamic analyses of plasma XXX, plasma FP and serum cortisol over 12 hours (selected US sites)
Sample 1
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Safety Endpoints 
Sample 1

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. Wet Weather 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 10.3.1 Where a teacher is considered to be working in an “eye danger” area, the teacher shall receive a personal issue of standard neutral safety glasses which shall remain the property of the employer.

  • 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 Contractor is required to ensure Material Safety Data Sheets (“MSDS”) are available, employees are trained in the use of MSDS, and MSDS are in a readily accessible place at the Site. This requirement applies to all materials with an associated MSDS per the federal “Hazard Communication” standard or employees’ Right-to-Know laws. Contractor is also required to ensure proper labeling and training on any substance brought onto the Site and that any person working with the material (or who is subject to possible exposure by use of the material or contact with the material), is informed of the possible and/or real hazards of the substance, and follows proper handling and protection procedures.

  • 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 classifications listed in Section 7 below, and employees who are currently required to wear safety footwear by Department Work Rules, an allowance of one hundred twenty dollars ($120.00) for replacement of safety footwear.

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