Exploratory Endpoints Sample Clauses

Exploratory Endpoints. Difference in disease progression according to RECIST 1.1 and iRECIST (Appendix 5) criteria • Compliance rate responding to a phone - based application for the assessment of patient defined symptoms • Improvement in symptoms as recorded by the Patient Personalized Clinical Benefit (PPCB) • Differences in tumor and/or tissue texture on CT scan between the two treatment arms • Differences in gut microbial communities within and between fecal samples using alpha and beta diversity metrics based on 16S rRNA sequencing
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Exploratory Endpoints. Treatment related mortality rate 100 days post allogeneic stem cell transplant (TRM-Allogeneic SCT 100 day survival)Overall survival from the time of allogeneic stem cell transplant (OS-Allogeneic SCT): OS-Allogeneic SCT is evaluated in subjects who undergo allogeneic SCT and is defined as the time from allogeneic SCT to the date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date. • Complete Remission with partial Hematological Recovery (CRh). The incidence of a CRh (see Appendix 1 for definition). All subjects that do not meet the criteria for CRh by the analysis data cutoff date will not be considered to have CRh. • Blast-free hypoplastic or aplastic bone marrow rate: The incidence of blast-free hypoplastic or aplastic bone marrow (see Appendix 1 for definition). All subjects who do not meet the criteria for blast-free hypoplastic or aplastic bone marrow by the analysis date cutoff date will not be considered to have blast-free hypoplastic or aplastic bone marrow. • Partial remission (PR) rate: The incidence of PR (see Appendix 1 for definition). All subjects that do not meet the criteria for PR by the analysis data cutoff date will not be considered to have PR. • The overall complete remission rate (CR and CRi), MRD-negative rate, and DOR among subjects retreated with KTE-X19 (Section 7.11.10) • Level and activity of CAR+ T cells, as well presence CD19+ cells in blood and bone marrow. • Levels of cytokines in serum and CSF.
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Exploratory Endpoints. ● The pharmacokinetics (PK) of LB100 and its metabolite endothall. ● The relative abundance of immune cell populations before, during and after treatment. The signaling states that evolve in immune cells during treatment and that differentiate responders from non-responders.
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Exploratory Endpoints. PD Endpoints STATISTICAL ANALYSIS PLANS: Sample Size:
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Exploratory Endpoints. PHARMACODYNAMIC ENDPOINTS
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Exploratory Endpoints. CST area under the curve (AUC) • Percent of eyes with resolution of fluid (sub-retinal fluid and intraretinal cysts) through week 12 on SD-OCT Additional details on endpoints will be included in the statistical analysis plan.
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Exploratory Endpoints. ‌ Additional exploratory analyses will be conducted to evaluate effects of treatment on Impact of Weight on Quality of Life-Kids (IWQOL-Kids) questionnaire scores, changes in various glycemic and lipid markers, and change in BMI Z-score.
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Exploratory Endpoints. Exploratory endpoints are provided below. The analysis and subsequent results of these assessments may be reported in separate documents and not included in the Statistical Analysis Plan or Clinical Study Report, respectively. • EORTC QLQ-C30/OV-28, EQ5D-5L, and PGIS • PK parameters will not be calculated due to the use of a sparse sampling schedule. Summary statistics of intact ADC, total Ab, DM4 and S-methyl DM4 concentration data by time will be presented • Immunogenicity is defined as the presence of ADA to MIRV. Based on seroconversion status, the impact of ADA on both efficacy and safety will be evaluated • Identification of soluble FRα levels and other biomarkers, such as protein, genetic, and/or gene expression changes, related to solid malignancies and/or MIRV or IC Chemo mechanism of action. Patient samples will only be used for exploratory research related to this trial and the development of MIRV 3.1. Criteria for Selection of Patient Population 3.1.1. Inclusion Criteria 1. Female patients ≥ 18 years of age 2. Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer 3. Patients must have platinum-resistant disease: a. Patients who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between > 3 months and ≤ 6 months after the date last dose of platinum b. Patients who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression Note: Patients who are platinum-refractory during front-line treatment are excluded (see exclusion criteria) 4. Patients must have progressed radiographically on or after their most recent line of therapy 5. Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity 6. Patient’s tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay 7. Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator) 8. Patients must have received at least 1 b...
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Exploratory Endpoints. XXX and duration of second response among subjects retreated with anti‑CD19 CAR T cells (Section 7.12.10)
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Related to Exploratory Endpoints

  • 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.

  • 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.

  • Career Development The City and the Union agree that employee career growth can be beneficial to both the City and the affected employee. As such, consistent with training needs identified by the City and the financial resources appropriated therefore by the City, the City shall provide educational and training opportunities for employee career growth. Each employee shall be responsible for utilizing those training and educational opportunities made available by the City or other institutions for the self- development effort needed to achieve personal career goals.

  • 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.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Feasibility Study A feasibility study will identify the potential costs, service quality and other benefits which would result from contracting out the work in question. The cost analysis for the feasibility study shall not include the Employer’s indirect overhead costs for existing salaries or wages and benefits for administrative staff or for rent, equipment, utilities, and materials, except to the extent that such costs are attributable solely to performing the services to be contracted out. Upon completion of the feasibility study, the Employer agrees to furnish the Union with a copy if the feasibility study, the bid from the Apparent Successful Bidder and all pertinent information upon which the Employer based its decision to contract out the work including, but not limited to, the total cost savings the Employer anticipates. The Employer shall not go forward with contracting out the work in question if more than sixty percent (60%) of any projected savings resulting from the contracting out are attributable to lower employee wage and benefit costs.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Development Within twenty (20) Working Days after the Commencement Date and in accordance with paragraphs 3.10 to 3.12 (Amendment and Revision), the Contractor will prepare and deliver to the Authority for approval the full and final Security Plan which will be based on the draft Security Plan set out in Appendix B.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

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