Secondary endpoints. Secondary safety endpoints include: · change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index, left ventricular mass) · change from baseline in regional (infarct related) and global wall motion score · change from baseline in ejection fraction · cardiac rupture · NT-proBNP 4 Investigational Plan
Secondary endpoints. The secondary endpoints of this clinical trial include:
Secondary endpoints. To cross-validate the prediction models in order to assess the accuracy of their performance in clinical practice and to test their generalizability. This will take place through bootstrapping methods and, mainly, through data splitting. Specifically, through sophisticated sampling methods, the dataset will be split into two: one part of the dataset will be used so as to develop and train the model; the other part will be used to validate it. Proposed prediction models are detailed below. • To identify processes and interactions that can more accurately predict final (i.e., at 18 months) and intermediate (i.e., at 3, 6, 9, 12 and 15 months) psychological outcomes. • To develop a multi-dimensional index of resilience as a function of the biomedical status (BMS), the psychosocial status (PSS) and the functional status (FUS) of the patient. • To deliver an advanced, empirically validated and more inclusive definition of resilience. • To perform a series of moderation, multiple mediation and moderated mediation analyses (e.g., from personality traits to health outcomes, through health-related beliefs and behaviour, with socio-demographic variables as moderating conditions) in order to gain an enhanced understanding of the dynamic process of adaptation to breast cancer, and resilience-as-a-process. • To conduct cost-benefit analysis in order to assess the strengths and limitations of the project outcomes and also determine the best approach to achieve the maximum benefits. • To examine potential differences in the predictive and outcome variables across the four clinical sites of the BOUNCE Pilot Study considering also health care infrastructures and patient flow/support/culture.
Secondary endpoints. [***] from [***] will be [***] the [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
Secondary endpoints. The secondary outcomes will be the subject’s degree of discomfort and/or pain as measured by the visual analogue scale (VAS), the incidence of spontaneous adverse events (AEs) and the investigator’s assessment of improvement using the Xxxxxxxxxxx Wrinkle and Elastosis Scale scores beforeand after treatment as well as Global Aesthetic Improvement Scale (GAIS) for each subject.
Secondary endpoints. Symptoms (angina score, NYHA class) within 1 year • Death, myocardial infarction and repeat revascularisation as individual components of XXXX • Cost-effectiveness of an MR vs FFR guided selection for revascularisation • Occurrence of new myocardial scar tissue • Ischaemia reduction in the FFR vs MR group after therapy Table 3.4: Detailed definition of end-points End Point Definition Death All cause mortality Myocardial Spontaneous Elevation of CK or Troponin Infarction above baseline with symptoms of ischaemia, ECG changes or imaging evidence of loss of myocardium(123) Peri- procedural CKMB>3X ULN- upper limit of normal (post PCI 12-24hrs) CKMB>5X ULN (post CABG 24-72 hours) plus new Q waves or LBBB, new native vessel or graft occlusion, imaging evidence of loss of viable myocardium(123) Repeat Repeat PCI or CABG of the target revascularisation lesion performed for restenosis or other complication of the target lesion (from 5mm proximal to 5mm distal to the stent) (124)
Secondary endpoints. IRRC-assessed XXX and PFS, and OS, in any-risk subjects with previously untreated RCC. Incidence of AEs in all treated subjects with previously untreated advanced or metastatic RCC Exploratory Endpoints: Overall safety and tolerability of NIVO+IPI versus sunitinib. IRRC-assessed XXX and PFS, and OS in favourable-risk subjects with previously untreated advanced or metastatic RCC. Explore potential predictive biomarkers of clinical response by analyzing tumor specimens and blood samples for proteins and genes involved in regulating immune responses. Evaluate HRQoL as assessed by FACT-G. Assess disease related symptoms in each arm based on NCCN FKSI-19. Assess changes in global health status based on EuroQol’s EQ-5D. Abbreviations: AE: adverse event; EQ-5D: EuroQoL 5-Dimensions; FACT-G: Functional Assessment of Cancer Therapy-General; FKSI-19: Functional Assessment of Cancer Therapy-Kidney Symptom Index; HRQoL: health- related quality of life; IRRC: Independent radiological review committee; IV: intravenous; NCCN; National Comprehensive Cancer Network: NIVO+IPI; nivolumab plus ipilimumab; XXX: Overall Response Rate, OS: Overall Survival, PFS: Progression free survival, Q2W: every 2 weeks, Q3W: every 3 weeks, RCC: renal cell carcinoma.
Secondary endpoints. To describe the resilience scores at baseline and during and after the targeted interventions and to compare the results to a control population of the former BOUNCE prospective pilot study without interventions. The information about the usability of the tool and targeting the interventions will be collected from the trial nurse using the tool.
Secondary endpoints. ● Objective response rate (OXX) as defined by RECIST v1.1 (Appendix B) Patients who respond to treatment and die without PD (including death from study disease), duration of response will be censored at the date of the last objective progression-free disease assessment. For responding patients not known to have died as of the data cut-off date and who do not have PD, duration of response will be censored at the last progression-free assessment date. For responding patients who receive subsequent anticancer therapy (after discontinuation from all study treatment excluding PCI) prior to disease progression, duration of response will be censored at the date of last progression-free assessment prior to the initiation of post discontinuation anticancer therapy ● Duration of overall response as defined by RECIST v1.1 (Appendix B) ● Safety and Adverse events by assessed by CTCAE version 5.0 ● Progression-free survival (PFS) as defined by RECIST v1.1 (Appendix B) ● Overall survival, which is defined as the time from the date of study enrollment to the date of death from any cause. For patients who are still alive as of the data cutoff date, OS time will be censored on the date of the patient’s last contact (last contact for patients in post discontinuation is last known alive date in mortality status).
Secondary endpoints. Length of stay o Aim: Decrease length of hospital stay o Measured: Time (Hours) • Length of time for initial image processing o Aim: Decrease disturbance to surgeon workflow o Measured: Time (Minutes) • Length of time to place all screws o Aim: Reduce the time for screw placement o Measured: Time (Minutes) • Length of time to confirm screw placement o Aim: Reduce the time needed for confirmation of screw location o Measured: Time (Minutes) • Length of time to register images o Aim: To reduce time for registration of reference images o Measured: Time (Seconds) • Estimated Blood Loss (EBL) o Aim: To reduce the EBL of each case o Measured: Milliliters (mL) • Incidence of Malalignment o Aim: To decrease the incidence of pedicle screw malalignment o Measured: Misalignment angle between pilot hole and screw trajectory (degrees) • Complications: Neurological Deficits, Dural Tears, deep wound infections, etc o Aim: To decrease the incidence of intraoperative complications o Measured: number of reported complications while hospitalized • Measurement of 2D fluoroscopy radiation exposure o Aim: to reduce patient and surgeon exposure to radiation o Measured: Exposure measured by Dose Area Product (DAP)
