Primary Efficacy Endpoint Sample Clauses

Primary Efficacy Endpoint. Change from baseline in six-minute-walk distance (6MWD) relative to placebo at Week 24
Sample 1
AutoNDA by SimpleDocs
Primary Efficacy Endpoint. Review by a central radiologist, blinded to subject treatment assignments and independent from the clinical sites, will assess all tumor responses. The resulting response data will serve as primary clinical efficacy data for the trial. Deaths on study will also contribute to the PFS endpoint. PFS is defined as the duration of time from randomization to time of irPD or death, whichever comes first, or the last tumor assessment date for censored subjects. The primary efficacy endpoint, PFS, will be summarized and displayed by treatment group using Xxxxxx-Xxxxx methods (SAS® PROC LIFETEST). Point estimates (25th, 50th, and 75th percentiles) will be provided, along with a 1-sided 90% confidence interval (CI). Treatments will be compared for the ITT population using a stratified log-rank test, with randomization stratification factors included, as the primary analysis. The HR between the 2 study arms, as well as the associated 90% CI, will be presented using Xxx proportional hazards regression (SAS® PROC PHREG) controlling for randomization stratification factors. Xxxxxx-Xxxxx plots will be presented. The primary analysis will be a stratified log-rank test (using the randomization stratification factors) comparing PFS between the 2 randomized arms in the ITT population.
Sample 1
Primary Efficacy Endpoint. The primary endpoint of this study is all-cause mortality in the 3 years post-randomisation amongst all subjects randomised to treatment.
Sample 1

Related to Primary Efficacy Endpoint

  • 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.

  • 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: minimum 21 days/3 weeksuntil patient’s weight >2000g, averaged 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months following enterostomy closure (12- month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 months of overall study duration).

Time is Money Join Law Insider Premium to draft better contracts faster.