Safety Endpoints Sample Clauses

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).
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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.
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
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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
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
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
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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
Sample 1
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Safety Endpoints 
Sample 1

Related to Safety Endpoints

  • 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.

  • Periodic Review of Costs of Environmental Compliance In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Environmental, Health and Safety Matters (a) The Company has complied and is in compliance with all Environmental, Health, and Safety Requirements.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • O.S.H.A. and Environmental Compliance (a) Each Borrower has duly complied with, and its facilities, business, assets, property, leaseholds, Real Property and Equipment are in compliance in all material respects with, the provisions of the Federal Occupational Safety and Health Act, the Environmental Protection Act, RCRA and all other Environmental Laws; there have been no outstanding citations, notices or orders of non-compliance issued to any Borrower or relating to its business, assets, property, leaseholds or Equipment under any such laws, rules or regulations.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Environmental Studies Promptly conduct and complete, at Borrower’s expense, all such investigations, studies, samplings and testings as may be requested by Lender or any governmental authority relative to any substance, or any waste or by-product of any substance defined as toxic or a hazardous substance under applicable federal, state, or local law, rule, regulation, order or directive, at or affecting any property or any facility owned, leased or used by Borrower.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower's part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower's part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Environmental, Health and Safety i. Environment, Health and Safety Performance. Seller acknowledges and accepts full and sole responsibility to maintain an environment, health and safety management system ("EMS") appropriate for its business throughout the performance of this Contract. Buyer expects that Seller’s EMS shall promote health and safety, environmental stewardship, and pollution prevention by appropriate source reduction strategies. Seller shall convey the requirement of this clause to its suppliers. Seller shall not deliver goods that contain asbestos mineral fibers.

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