Sample Size Considerations Sample Clauses

Sample Size Considerations. Sample size calculations based on various incidence rates in the control arm, relative vaccine efficacies for those in the MVA-NP+M1 arm, and alpha levels (two-sided) are provided in Table 7-1. All calculations assume 80% power and given this is a proof of concept study an alpha of 0.1 is chosen for powering analyses. Based on the projected range of incidence rates in the control arm, a total sample size of approximately 5000 to 6000 participants over two influenza seasons is expected to provide approximately 80% power to detect a meaningful vaccine efficacy (approximately 35%) in the MVA-NP+M1 arm. After the first influenza season, which will enrol approximately 2,200 participants, a sample size recalculation may be performed on the basis of the observed relative vaccine efficacy of MVI-NP+M1 during the first influenza season. This will be described in more detail in the SAP.
Sample 1Sample 2
AutoNDA by SimpleDocs
Sample Size Considerations. The primary endpoint is the percentage of patients progressing at 6 months. Based on a contemporary control of no maintenance after best response to prior chemotherapy8, the control arm with pembrolizumab alone is expected to have only 8% of patients with no progression at 6 months. To be of clinical interest, at least 58% of patients must be progression-free at 6 months on the pembrolizumab plus paricalcitol arm. A sample size of 12 patients per arm will provide 90% statistical power to detect this difference assuming a one-sided alpha level of 0.05. A one-sided test was selected as we are only interested in the combination if it decreases the percentage of patients progressing at 6 months. This sample size estimate was obtained using binomial enumeration of all possible outcomes to compare two independent binomial proportions (Xxxxxxx’x xxx-squared test) using PASS 15.18 A statistical concern is that the Xxxxxxx xxx-squared test does not guarantee the alpha level. We confirmed that we have adequate statistical power using the Miettinen & Nurminen 19 exact likelihood score method (89% power) using Pass 15.
Sample 1
Sample Size Considerations. The design of the particular retrospective study has an observational character focusing on a specific disease i.e. breast cancer. The aim is to analyse the relationships between biological, psychological and social factors and their influence on resilience among breast cancer patients. Given the number and the heterogeneity of the clinical centres involved in the BOUNCE project, it is not possible to predict a priori the optimal sample size. The goal is to collect as many data sets as possible, in order to obtain the most representative sample.
Sample 1
Sample Size Considerations. The anticipated enrollment in this study is approximately 100 subjects. The primary efficacy endpoint and all analyses based on the response will be based on a mITT population consisting of all subjects who receive any dose of KTE-X19 in Phase 2. This study uses a single-arm design to test for an improvement in overall complete remission rate. For the test of efficacy this study has approximately 93% power to distinguish between an active therapy with a 65% true overall complete remission rate from a therapy with an overall complete remission rate of 40% or less with a 1-sided alpha level of 0.025. A step-down test of the secondary endpoint MRD-negative Rate will be performed against a MRD-negative rate of 30% if the testing of the overall complete remission rate is significant. In Phase 1, the SRT will review safety data after 3 subjects in the DLT evaluable set (see Section 10.5) have had the opportunity to be followed for 28 days after the KTE-X19 infusion. If the conditioning regimen and KTE-X19 dose evaluated in Phase 1 is determined to be safe based on the incidence of DLT, up to approximately 30 additional subjects may be enrolled to further evaluate safety prior to commencing Phase 2. During Phase 2, one interim and one primary analyses will be performed. The interim analysis is for safety only and will occur after 20 subjects have been treated with KTE-X19 and have had the opportunity to be followed for 30 days after the KTE-X19 infusion. The primary analysis will occur when the overall study enrollment is complete and all subject in the mITT set have had the opportunity to complete the month 6 disease assessment. 65% Approximately 100 subjects may be enrolled into the entire study. At the time of the primary analysis, in the event that either less than or more than 50 subjects are eligible for the mITT set, all mITT eligible subjects will be included in the analysis.
Sample 1
Sample Size Considerations. In the Phase 1b dose escalation, at least 9 participants are expected to be enrolled. The sample size was determined empirically and is consistent with those used in this type of initial human clinical study. A total of at least 108 additional participants are expected to be treated in the Phase 2a (dose expansion) with OPT-302 at the MTD or highest dose tested from the Phase 1b, in combination with aflibercept (72 participants) or with aflibercept alone (36 participants). Increasing numbers of participants will be exposed in the various phases of the trial: • In the Phase 1b dose escalation, if 3 participants will be treated with OPT-302 per cohort (without dose limiting toxicity), a total of at least 9 participants will be treated in this phase of the trial. • In the Phase 2a dose expansion, 72 additional participants will be enrolled at the MTD or the highest dose level of OPT-302 (determined from the Phase 1b). In case one or more of these 72 participants are not evaluable, randomization will continue and more patients will receive the same dose. • A total of up to at least 81 participants receiving OPT-302 is anticipated to be enrolled in the trial (9 in Phase 1b and 72 in Phase 2a). The table below shows the true proportion of patients with an AE that can be ruled out at various confidence levels, assuming no such event is observed in the trial. In the Phase 2a dose expansion, subjects will be allocated in a 2:1 ratio to one of two treatment groups, aflibercept with OPT-302 or aflibercept with sham, with minimization for two baseline characteristics: BCVA (≤ 55 vs. > 55 letters) and CST (≤ 450 vs. > 450 µm). The primary outcome of the Phase 2a is the proportion of evaluable patients with a response of ≥ 5 letter gain in BCVA from baseline to week 12 according to ETDRS criteria in the combination aflibercept + OPT-302 group. The design of the trial is non-comparative in so far as the sample size is calculated for the aflibercept + OPT-302 arm only. A one-stage design is used for the primary outcome (Xxxxxxx 2001) of the aflibercept + OPT-302 arm. A formal rule allows for the assessment of the observed response rate as compared with pre-specified “low” and high response rates. Specifically, the hypotheses of interest are H0: r ≤ r0 (“low” response rate) against HA: r ≥ rA (“high” response rate). The following assumptions were made for sample size calculations: o the pre-specified “low” and “high” response rates are r0 = 0.28 and rA = 0.45 o the type I ...
Sample 1
Sample Size Considerations. Total of 280 patients in 2 groups of equal size (140 per group) Primary comparison: Obeticholic acid group vs. Placebo group Primary outcome measure: Histological improvement in NAFLD (defined above) Error protection: Type I= 0.05 and Type II= 0.10 (90% power) Missing data: 10% will not have 72 week biopsies and will be considered not improved Minimum clinically important difference: 50% higher relative rate of improvement in the obeticholic acid group vs. the placebo group Assumed response rates: 1. Expected percent with improved NAFLD (defined above) in the placebo group: 39% (based on PIVENS data and 2 to 1 split for patients on vs. not on vitamin Eat start of trial) 2. Expected percent with improved NAFLD in the obeticholic acid group: 58%
Sample 1
Sample Size Considerations. This study uses an open-label, 2-cohort design to test for an improvement in XXX. Up to approximately 130 subjects with r/r MCL will be enrolled and treated with anti‑CD19 CAR T cells, including 10 axicabtagene ciloleucel subjects and up to approximately 80 KTE-X19 subjects in Cohort 1 and up to 40 KTE-X19 subjects in Cohort 2. The primary analysis will be conducted after 60 Cohort 1 KTE-X19 subjects have been enrolled and treated and have had the opportunity to be evaluated for response 6 months after the Week 4 disease assessment. For the test of efficacy, 60 KTE-X19 subjects in Cohort 1 will provide at least 96% power to distinguish between an active therapy with a 50% true response rate from a therapy with a response rate of 25% or less (undesirable response rate, for purposes of futility assessment) with a 1-sided alpha level of 0.025. No hypothesis will be tested in Cohort 1 axicabtagene ciloleucel subjects or Cohort 2 subjects. Exploratory analyses will be conducted on the data collected from these subjects. In Cohort 1, 4 interim analyses will be performed: • Cohort 1 interim analysis 1 will be conducted after 10 subjects in Cohort 1 have been enrolled and treated with anti‑CD19 CAR T cells and have had the opportunity to be followed for 30 days. This interim analysis will be for safety only. • Cohort 1 interim analysis 2 will be conducted after 20 subjects in Cohort 1 have been enrolled and treated with anti‑CD19 CAR T cells and have had the opportunity to be evaluated for response 3 months after treatment with anti‑CD19 CAR T cells. In this interim analysis, the DSMB will review data for both safety and efficacy (futility only). • Cohort 1 interim analysis 3 will occur after 38 subjects in Cohort 1 have been treated with anti‑CD19 CAR T cells and have had the opportunity to be assessed for response 6 months after the treatment with anti‑CD19 CAR T cells. This interim analysis will be performed for a Kite internal review of the accumulating data of safety and efficacy. • Cohort 1 interim analysis 4 will occur after 44 subjects in Cohort 1 have been treated with anti‑CD19 CAR T cells and have had the opportunity to be followed for at least 30 days. In this interim analysis, the DSMB will review data for safety only, with focus on the 6 KTE-X19 subjects treated most recently in this cohort. In Cohort 2, one interim analysis will be performed: • Cohort 2 interim analysis will be conducted after 10 subjects in Cohort 2 have been enrolled and treated w...
Sample 1
AutoNDA by SimpleDocs
Sample Size Considerations. Sample size is determined by the number of patients who participated in the previous phase III Study (RP103-03) and any additional patients, who did not complete the RP103-03 study, who enroll after all patients that participated in RP103-03 have completed and data have been analyzed.
Sample 1

Related to Sample Size Considerations

  • Special Considerations The Provider position may be abolished at any time by the Collin County Commissioners Court.

  • General Considerations a. All reports, drawings, designs, specifications, notebooks, computations, details, and calculation documents prepared by Vendor and presented to the Board pursuant to this Agreement are and remain the property of the Board as instruments of service. b. All analyses, data, documents, models, modeling, reports and tests performed or utilized by Vendor shall be made available to the Board upon request and shall be considered public records. c. Vendor is required to: (i) keep and maintain public records required by Board; (ii) upon request from Board’ s custodian of public records, provide Board with a copy of the requested records or allow the records to be inspected or copied within a reasonable time at a reasonable or as otherwise provided by law; (iii) ensure that public records that are exempt or, confidential and exempt, from public records disclosure requirements are not disclosed except as authorized by law for the duration of this Agreement and following completion of this Agreement if Vendor does not transfer the records to Board; (iv) upon completion of this Agreement, transfer, at no cost, to Board all public records in possession of Vendor or keep and maintain public records required by Board. d. If Vendor transfers all public records to Board upon completion of this Agreement, Vendor shall destroy any duplicate public records that are exempt or, confidential and exempt, from public records disclosure requirements. If Vendor keeps and maintains public records upon completion of this Agreement, Vendor shall meet all applicable requirements for retaining public records. All records stored electronically must be provided to Board, upon request from Board’s custodian of public records, in a format that is compatible with the information technology systems of Board. e. Vendor shall keep all books, records, files, drawings, plans and other documentation, including all electronically stored items, which concern or relate to the services required hereunder (the “Records”), for a minimum of five (5) years from the date of expiration or suspension of this Agreement, or as otherwise required by any applicable law, whichever date is later. The Board shall have the right to order, inspect, and copy all the Records as often as it deems necessary during any such period-of-time. The right to audit, inspect, and copy Records shall include all of the records of sub-Vendors (if any). f. Vendor shall, at all times, comply with the Florida Public Records Law, the Florida Open Meeting Law and all other applicable laws, rules and regulations of the State of Florida. g. IF THE VENDOR HAS QUESTIONS REGARDING THE APPLICATION OF CHAPTER 119, FLORIDA STATUTES, TO THE VENDORS’ DUTY TO PROVIDE PUBLIC RECORDS RELATING TO THIS AGREEMENT, CONTACT THE CUSTODIAN OF PUBLIC RECORDS AT 000-000-0000, Sumter County Board of County Commissioners, 0000 Xxxxxx Xxxx, Wildwood, Florida 34785 or via email at Xxxxxxx@xxxxxxxxxxxxxx.xxx. h. Vendor shall, at all times, carry General Liability, and Worker’s Compensation Insurance pursuant to the insurance requirements in RFP 000-0-0000/JV, naming Board as both a certificate holder and an additional insured in each such policy. i. Upon Vendor’s written request, the Board will furnish, or cause to be furnished, such reports, studies, instruments, documents, and other information as Vendor and Board mutually deem necessary, and Vendor may rely upon same in performing the services required under this Agreement. j. Vendor is obligated by this agreement to comply with Section 20.055(5), Florida Statutes. k. Any entity or affiliate who has had its Certificate of Qualification suspended, revoked, denied or have further been determined by the Department to be a non-responsive contractor may not submit a bid.

  • Other Considerations A. Changes to an Approved Scope of Work: The Recipient(s) shall notify FEMA and shall require a subrecipient to notify it immediately when a subrecipient proposes changes to an approved scope of work for an Undertaking. 1. If FEMA determines the change meets a Programmatic Allowance or has no effect on the property, FEMA shall approve the change. 2. If the change can be modified to meet a Programmatic Allowance, or conform to any applicable SOI Standards, FEMA shall conclude its Section 106 review responsibilities. 3. If FEMA determines that the change does not meet an Allowance, FEMA shall initiate consultation pursuant to Stipulation II.C, Standard Project Review. B. Unexpected Discoveries, Previously Unidentified Properties, or Unexpected Effects: 1. Upon notification by a subrecipient of an unexpected discovery, or if it appears that an Undertaking has affected a previously unidentified property or affected a known historic property in an unanticipated manner, in accordance with Stipulation I.B.3(e), Recipient(s) Roles and Responsibilities, the Recipient(s) shall immediately notify FEMA and require the subrecipient to: a. Stop construction activities in the vicinity of the discovery. b. Take all reasonable measures to avoid or minimize harm to the property until FEMA has completed consultation with the SHPO, participating Tribe(s), and any other consulting parties. Upon notification by the Recipient of a discovery, FEMA shall immediately notify the SHPO, participating Tribe(s), and other consulting parties that may have an interest in the discovery, previously unidentified property or unexpected effects, and consult to evaluate the discovery for National Register eligibility and/or the effects of the Undertaking on historic properties. c. If human remains are discovered, cease work at that location immediately and contact the Wisconsin Historical Society Burial Sites Preservation Program office at (000) 000-0000 for further instruction pursuant to Wis. Stat. § 157.70 and Wis. Admin. Code § HS 2. Discoveries of human remains on Federal or Tribal lands shall be subject to the Native American Xxxxxx Protection and Repatriation Act (NAGPRA) (25 U.S.C. §3001-3013, 18 U.S.C. § 1170) and ARPA, as applicable. d. Assist FEMA in completing the following actions, as required: i. FEMA shall consult with the SHPO, participating Tribe(s), and other consulting parties in accordance with the consultation process outlined in Stipulation II, Project Review, to develop a mutually agreeable action plan with timeframes to identify the discovery or previously unidentified property, take into account the effects of the Undertaking, resolve adverse effects if necessary, and ensure compliance with applicable Federal, State, and local statutes. ii. FEMA shall coordinate with the Recipient(s) and the subrecipient regarding any needed modification to the scope of work for the Undertaking necessary to implement recommendations of the consultation and facilitate proceeding with the Undertaking. iii. In cases where discovered human remains are determined to be Native American, FEMA shall consult with the appropriate Tribal representatives and SHPO, consistent with all provisions of Wis. Stat. § 157.70 and NAGPRA, if applicable. In addition, FEMA shall follow the guidelines outlined in the ACHP’s Policy Statement Regarding the Treatment of Burial Sites, Human Remains, and Funerary Objects (2007) and the Wisconsin Archeological Survey’s Guide for Public Archeology in Wisconsin.

  • Additional Considerations For each mediation or arbitration: (i) Any mediation or arbitration will be held in New York, New York, at the offices of the mediator or arbitrator or at another location selected by CNHICA or the Seller. Any party or witness may participate by teleconference or video conference. (ii) CNHICA, the Seller and the Requesting Party will have the right to seek provisional relief from a competent court of law, including a temporary restraining order, preliminary injunction or attachment order, if such relief is available by law. (iii) Neither the Servicer, CNHICA nor the Seller will be required to produce personally identifiable customer information for purposes of any mediation or arbitration. The existence and details of any unresolved Repurchase Request, any informal meetings, mediations or arbitration proceedings, the nature and amount of any relief sought or granted, any offers or statements made and any discovery taken in the proceeding will be confidential, privileged and inadmissible for any purpose in any other mediation, arbitration, litigation or other proceeding. The parties will keep this information confidential and will not disclose or discuss it with any third party (other than a party’s attorneys, experts, accountants and other advisors, as reasonably required in connection with the mediation or arbitration proceeding under this Section 3.3), except as required by law, regulatory requirement or court order. If a party to a mediation or arbitration proceeding receives a subpoena or other request for information of the other party to the mediation or arbitration proceeding, the recipient will promptly notify the other party and will provide the other party with the opportunity to object to the production of its confidential information.

  • MEMO OF CONSIDERATION RECEIVED on the day month and year first above written of and from the within named Purchasers the within mentioned sum of Rs. /- (Rupees only)paid as and by way of full consideration in terms of these presents. 1 By cheque no. dated 2 By cheque no. dated 3 By cheque no. dated 4 By cheque no. dated 5 By cheque no. dated 6 TDS ( ) 7 By cheque no. dated TOTAL (RUPEES ONLY) 1. (OWNERS)

  • Share Consideration Nation Energy Inc., a Wyoming corporation, has agreed to issue on December 17, 2015 600,000,000 of its common shares (the Share Consideration) to Paltar, and Paltar has agreed to certain restrictions on the transfer of such shares, under the terms of the Third Amended and Restated Letter Agreement, dated 30 August 2015 between Nation Energy Inc. and Paltar (the Letter Agreement), in the event that an Exchange Transaction (as defined in the Letter Agreement) has not been consummated on or before December 16, 2015.

  • Settlement Consideration In consideration of the full settlement, satisfaction, compromise and release of the Released Plaintiffs’ Claims, an aggregate $115 million in cash (the “Escrow Amount”) shall be paid on behalf of the Settling Defendants to Freeport by the D&O Carriers. The Settling Defendants shall cause the Escrow Amount to be deposited by the D&O Carriers into an interest-bearing escrow account controlled by an agreed upon representative of Plaintiffs and of the Settling Defendants (the “Escrow Account”) within fifteen (15) business days after the Stipulation is submitted to the Court. Upon the Effective Date, the Escrow Amount, together with any and all interest thereon, shall be paid to Freeport from the Escrow Account. For the avoidance of doubt, the Settling Defendants shall have no obligation to deposit any portion of the Escrow Amount into the Escrow Account but shall have an obligation to take all reasonably available steps to seek to cause the D&O Carriers to deposit the Escrow Amount into the Escrow Account.

  • Initial Consideration On the Effective Date, Retrocessionaire shall reimburse Retrocedant for one hundred percent (100%) of any and all unearned premiums paid by Retrocedant under such Inuring Retrocessions net of any applicable unearned ceding commissions paid to Retrocedant thereunder.

  • Financial Considerations 5.1 In the event aggregate funding provided to SCDDO from county, state and/or federal sources is reduced or in any way becomes insufficient to fund this Agreement, the obligations of both SCDDO and the CSP must thereupon be: (1) reduced on a pro rata basis, or (2) renegotiated or terminated, provided that any termination of this Agreement must be without prejudice to any obligations or liabilities of the parties accrued prior to the termination. 5.2 Upon discovery thereof, the CSP, or its employees, subcontractors or authorized agents will report to SCDDO any suspected or identified abuse, fraud or waste related to funds as identified in this Agreement. For the CSP’s convenience, SCDDO provides access to “Our Workplace” to report such suspected abuse, fraud or waste. Our Workplace may be accessed via the internet at xxx.XxxXxxxxxxxx.xxx (ID SCDDO615), or via phone at (000) 000-0000. The CSP agrees to post printed information on Our Workplace in an area accessible by its employees. The CSP also agrees to ensure that its employees are educated on abuse, fraud and waste and have a means to report suspected incidents thereof. Training on abuse, fraud and waste is available through Relias.

  • Total Consideration The aggregate consideration (the "Consideration") payable by the Surviving Partnership in connection with the merger of the Merged Partnership with and into the Surviving Partnership shall be $9,580,000., subject to adjustments at Closing pursuant to Section 3.9 and costs paid pursuant to Section 3.10(c) and Section 3.11, plus the amount of any tax or other reserves held by the Existing Lender (hereinafter defined).

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!