Secondary Efficacy Endpoints Sample Clauses

Secondary Efficacy Endpoints. 11.2.3.2.1 Stage 1 Secondary Efficacy Endpoints 11.2.3.2.2 Stage 2 Secondary Efficacy Endpoints
Sample 1
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Secondary Efficacy Endpoints. The change from baseline in eGFR in bardoxolone methyl-treated patients relative to placebo at Week 100. • The change from baseline in eGFR in bardoxolone methyl-treated patients relative to placebo at Week 104 following a 4-week drug treatment withdrawal period.
Sample 1
Secondary Efficacy Endpoints. Secondary efficacy endpoints will include: • Rate of moderate COPD exacerbations (defined as requiring treatment with systemic corticosteroids and/or antibiotics) and severe COPD exacerbations (defined as requiring hospitalisation) • Quality of Life determined using the St. George’s Respiratory Questionnaire (SGRQ) • COPD-related mortality • On treatment mortality • “Treatment Failure” as the composite endpoint of either severe COPD exacerbation, initiation of LTOT, or on treatment mortality • Clinic post-bronchodilator FEV1 (assessed 24-weekly) • Number of withdrawals from treatment • Health status using the EuroQol (EQ-5D) Questionnaire • Healthcare resource utilisation, including primary care contacts and secondary care contacts and use of rescue/concurrent medications • Other exacerbation endpoints (time to first moderate or severe COPD exacerbation, rate of severe COPD exacerbations, time to first severe COPD exacerbation, rate of moderate and severe COPD exacerbations requiring systemic COPD exacerbations, time to first moderate or severe COPD exacerbation requiring systemic corticosteroids) These will include adverse events reported while on study drug and additional information on bone fractures that occurred. This is a multicentre, randomised, double-blind, parallel group study in subjects with COPD treated for a period of 156 weeks (3 years) with a two-week follow-up period. The follow-up period follows either completion of the treatment period or follows withdrawal from the study. Subjects who prematurely discontinue study drug will also be followed up for 156 weeks (3 years) from randomisation for assessment of survival, moderate and severe exacerbations and concomitant medications. The study subjects will be outpatients, all of whom must fulfil the entry criteria (see Protocol Section 3.2). All inhaled corticosteroids and inhaled long-acting bronchodilators will be discontinued at entry to the run-in period. Approximately 6040 subjects will be randomised from approximately 450 sites. The subjects will be randomised in a ratio of 1:1:1:1 to SERETIDE 50/500µg bd, salmeterol 50µg bd, fluticasone propionate 500µg bd or placebo.
Sample 1
Secondary Efficacy Endpoints. Secondary efficacy endpoints will include: • Rate of moderate COPD exacerbations (defined as requiring treatment with systemic corticosteroids and/or antibiotics) and severe COPD exacerbations (defined as requiring hospitalisation). • Quality of Life determined using the St. George’s Respiratory Questionnaire (SGRQ) • COPD-related mortality • On treatment mortality • Severe COPD exacerbation/LTOT/on treatment mortality • Clinic post-bronchodilator FEV1 (assessed 24-weekly) • Number of withdrawals from treatment • Health status using the EuroQol Questionnaire (EQ-5D) • Healthcare resource utilisation, including primary care contacts and secondary care contacts and use of rescue/concurrent medications. • Other exacerbation endpoints (time to first moderate or severe exacerbation, rate of severe exacerbations, time to first severe exacerbation, rate of moderate and severe exacerbations requiring systemic corticosteroids, time to first moderate or severe exacerbations requiring systemic corticosteroids). These will include adverse events reported while on study drug and additional information on bone fractures that occurred.
Sample 1
Secondary Efficacy Endpoints. ‌ The secondary endpoints are: • Percent of subjects achieving a reduction ≥ 5%, ≥ 10% and ≥ 15% of baseline BMI at Week 56; • Change from baseline in waist circumference at Week 56; • Change from baseline in fasting insulin and Whole Body Insulin Sensitivity Index (Matsuda) at Week 56; • Change from baseline in triglycerides and HDL-C at Week 56; • Change from baseline in blood pressure at Week 56.
Sample 1
Secondary Efficacy Endpoints. 11.5.2.1. Objective Response Rate 11.5.2.2. Overall Survival
Sample 1
Secondary Efficacy Endpoints. The secondary efficacy endpoints are described in the master protocol.
Sample 1
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Secondary Efficacy Endpoints. Time-to-first clinical improvement event consisting of a persistent change for any of the following: • Improvement by at least one WHO functional class • Increase from baseline in 6MWD by at least 10% • Decrease from baseline in creatine kinase (as a surrogate biomarker for muscle injury and inflammation) by at least 10% The persistence of the change in WHO functional class, 6MWD, or creatinine kinase must be confirmed by a successive assessment also meeting the defined criteria. The confirmatory assessment must be at least 14 days after the initial assessment, or at the next scheduled assessment.
Sample 1
Secondary Efficacy Endpoints 
Sample 1

Related to Secondary Efficacy Endpoints

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, 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, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies 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.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Target Population TREATMENT FOR ADULT (TRA) Target Population

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act. (B) All classes covered by this Agreement are designated special risk classes for drug testing purposes. Special risk means employees who are required as a condition of employment to be certified under Chapter 633 or Chapter 943, F.S. (C) An employee shall have the right to grieve any disciplinary action taken under section 112.0455, the Drug-Free Workplace Act, subject to the limitations on the grievability of disciplinary actions in Article 10. If an employee is not disciplined but is denied a demotion, reassignment, or promotion as a result of a positive confirmed drug test, the employee shall have the right to grieve such action in accordance with Article 6.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • 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.

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