Safety and Tolerability Sample Clauses

Safety and Tolerability. Please refer to the Investigator’s Brochure for a detailed discussion of safety findings for studies in healthy subjects, oncology, CKD, and PH patients with bardoxolone methyl.
Sample 1
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Safety and Tolerability. The safety data from all patients will be assessed on an ongoing basis. Safety and tolerability will be assessed using Dose limiting Toxicities (DLTs), adverse events (AEs), physical examination, ECGs, LVEF, laboratory and vital sign data as recorded on the CRF.
Sample 1
Safety and Tolerability. OPT-302 has demonstrated acceptable safety and tolerability up to 2 mg administered by repeat IVT dosing every 4 weeks either alone or in combination with the anti-VEGF-A therapy, ranibizumab (0.5 mg), in a Phase 1 first in human (FIH) study (OPT-302-1001) in 51 patients with nAMD. The Phase 1 study consisted of two parts: Part 1 was an open-label, sequential dose escalation (n=20; 0.3, 1 or 2 mg OPT-302 with 0.5 mg ranibizumab, or 2 mg OPT-302 monotherapy, in 4 cohorts of 5 patients each); Part 2 was a randomized dose expansion (n=31, 2 mg OPT-302 with 0.5 mg ranibizumab [n=23] or 2 mg OPT-302 monotherapy [n=8]). All study drugs were administered by IVT injection for three consecutive dosing cycles at 4 weekly intervals. Of the 51 patients enrolled, 19 (37%) were male, 32 (63%) were female, 10 (20%) had diabetes mellitus and 25 (49%) were treatment naïve, while 26 (51%) had received ≥ 3 prior IVT injections of anti-VEGF-A therapy. No dose-limiting toxicities (DLTs) were observed with OPT-302 at any IVT dose level up to 2 mg either in combination with anti-VEGF-A therapy or as a monotherapy, and the MTD was not reached. In addition, there was no evidence of OPT-302 related immunogenicity after IVT administration of OPT-302 doses up to 2.0 mg/eye. Overall, 100% of evaluable participants at Week 12 (n=49) maintained BCVA, defined as ≤15 letter loss from baseline. In addition, changes from baseline in anatomic measures (CST) on SD-OCT through to week 12, demonstrated no adverse safety signals in treatment naïve patients and those who showed a sub-optimal response to prior anti-VEGF-A therapy. In summary, OPT-302 was well tolerated at doses up to 2 mg when administered by repeat intravitreal injections once every 4 weeks, either in combination with anti-VEGF-A therapy (0.5 mg ranibizumab) or as a monotherapy.
Sample 1
Safety and Tolerability. Safety reporting in clinical investigations of medical devices shall be performed in line with the requirements of the Regulation (EU) 2017/745 – Medical Device Regulation (MDR) Article 80(2). The sponsor shall report, without delay to all Member States in which the clinical investigation is being conducted, all of the following by means of the electronic system referred to in MDR Article 73:
Sample 1

Related to Safety and Tolerability

  • Safety and Compliance The Company commits to make all management and employees aware of all the changes to the Occupational Health and Safety Act and Regulations. This should be done via training courses and or union seminars. The conducting of the training and or seminars shall be at times convenient to the company.

  • Safety Orientation All employees shall be certified in Safety Orientation. Safety Orientation shall consist of three parts: PART 1 - the CODC Interactive Rights and Responsibilities course; PART 2 - the XXXX course or equivalent, and PART 3 - Employer or Owner Project Specific Training. It is the responsibility of each employee to hold current certification and maintain certification in part 1 and Part 2. The Employer or Owner shall provide to each Employee before commencing work with PART 3 - Employer or Owner Project Specific Training. Each Employee shall be on the payroll and paid while receiving PART 3 training. As a condition of employment it is the sole responsibility of each and every employee to obtain, hold and maintain all current certification(s) in any and all legislated safety training requirements (i.e. WHMIS, Fall Arrest, etc.) that are trade specific. Supporting documentation of all legislated training must be provided by the employee to the Union prior to dispatch and to the employer upon hire and may be further requested by the employer at any time during the duration of their employment. Prior to the expiration of any certification, the Employer will notify the Employee of the pending expiration and give the Employee reasonable time to renew their certification. Further, prior to arriving at site, employees shall hold current qualification(s) for the specific tasks and equipment identified in the dispatch request. If the employee has to be trained after dispatch, all costs borne by the Employer shall be reimbursed by the Training Fund. The CODC Harassment Policy and Procedures, including the provisions regarding General Harassment and as amended from time to time shall be the minimum standard of this Agreement.

  • HEALTH, SAFETY AND ENVIRONMENT 41.1 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:

  • 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.

  • Safety and Protection 8.18.1 The Contractor shall be responsible for initiating, maintaining and supervising all safety precautions and programs in connection with the Work. The Contractor shall take all necessary precautions for the safety of, and shall provide the necessary protection to prevent damage, injury or loss to:

  • Accident Prevention Health and Safety Committee The Employer and the Union agree that they mutually to maintain standards of safety and health in the Hospital in order to prevent accidents, injury, and illness. ected or Recognizing its responsibilities under the applicable legislation, the Hospital agrees to accept as a member of its Accident Prevention Health and Safety Committee, at least one (1) representative sel appointed by the Union from amongst Bargaining Unit employees. Such Committee shall identify potential dangers and means of improving health and safety programs, and recommend actions to be taken to improve conditions related to safety and health. The Hospital agrees to co-operate reasonably in providing necessary information to enable the Committee its functions. Meetings shall be held every second month or more frequently at the call of the Chair if required. The Committee shall maintain minutes of meetings and make the Same available for review. Any representative appointed or accordancewith hereof shall serve for a term of one (1) calendar year from the date of appointment which may be renewed for further of one (1) year. Time off for such to attend meetings of the Accident Prevention Health and Safety Committee in accordance with the foregoing shall be granted, and any attending such meetings during their regularly scheduled hours of work shall not lose regular as a result of such The Union agrees to endeavour to obtain the membership in the observation of all safety rules and practices. Safety Shoes The Hospital will provide sixty dollars ($60.00) annually effective April and eighty dollars ($80.00) effective April to each employee who is required by the Hospital, as delineated below, to wear safety footwear during the of his duties. The Hospital will require employees the following functions to wear appropriate Engineering Services; Grounds; Transport; (only where frequently working in storage areas). (as determined by the Hospital) heavy carts on a regular basis, e.g., linen carts, food wagons. ARTICLE BULLETIN BOARDS The Employer shall provide bulletin that all employees will have access to them have the right to post notices of meetings and such other notices as may be of interest to the membership. The wage increase listed on a retroactive to contact,in writing (with a copy to the Union) at their last-known entitle who have left its employ, to advise them of their any retroactive wage adjustment. Any employees who have employees shall have notice from the Hospital in which to claim from the Hospital any adjustment to their remuneration entitlement. The retroactive payments shall be made by separate cheques to the employees so entitled within sixty (60) days from the date of ratification. All other adjustments shall be effective as set out specifically in this Collective Agreement.

  • Health and Safety Provisions The Employer shall continue to make and enforce provisions for the occupational health, safety, and security of employees. The Employer will respond to suggestions on the subject from the Union and the parties undertake to consult with a view to adopting and expeditiously carrying out reasonable procedures and techniques designed or intended to prevent or reduce the risk of employment injury and employment-related chronic illness.

  • 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 AND ACCIDENT PREVENTION In performing work under this Contract on State premises, Contractor shall conform to any specific safety requirements contained in the Contract or as required by law or regulation. Contractor shall take any additional precautions as the State may reasonably require for safety and accident prevention purposes. Any violation of such rules and requirements, unless promptly corrected, shall be grounds for termination of this Contract in accordance with the default provisions hereof.

  • ENVIRONMENT, SAFETY AND HEALTH PROTECTION (a) Seller shall perform this Agreement in a manner that ensures adequate protection for workers, the public, and the environment, and shall be accountable for actions of itself and its lower-tier subcontractors, agents and employees. Seller shall exercise a degree of care commensurate with the work and the associated hazards. Seller shall ensure that management of environment, safety and health (ES&H) functions and activities is an integral and visible part of Seller’s work planning and execution process. In the event that Xxxxxx fails to comply with this Agreement, Company may, without prejudice to any other legal or contractual rights, issue an order stopping all or any part of the work; thereafter a start order for resumption of work may be issued at Company’s discretion. Seller shall make no claim for an extension of time or for compensation or damages by reason of or in connection with such work stoppage. In addition, Company may require, in writing, that Seller remove from the work any employee the Company deems unsafe, incompetent, careless, or otherwise objectionable.

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