Secondary Efficacy Endpoints Sample Clauses

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
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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. 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) Other Efficacy Endpoints • 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) Safety Endpoints These will include adverse events reported while on study drug and additional information on bone fractures that occurred. Study Design 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. Planned Sample Size 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) Other Efficacy Endpoints • 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). Safety Endpoints These will include adverse events reported while on study drug and additional information on bone fractures that occurred.
Sample 1
Secondary Efficacy Endpoints. 11.2.3.2.1 Stage 1 Secondary Efficacy Endpoints [***]
Sample 1
Secondary Efficacy Endpoints. The secondary efficacy endpoints are described in the master protocol.
Sample 1
Secondary Efficacy Endpoints 
Sample 1
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Related to Secondary Efficacy Endpoints

  • 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.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the Regulatory Milestone Events set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-2, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

  • 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.

  • 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.

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput across the Berths, nor will Operator be obligated to accept Product that fails to meet the quality specifications set forth in the arrival notice.

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.

  • Product Quality 4.1 The following provisions shall apply to Product after Production:

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

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