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. 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)
Secondary endpoints. The secondary endpoints of the study are to compare the following between the two treatment groups: • Safety as measured by adverse events, including clinically significant changes in physical examination, peripheral blood hematology, serum chemistry, urinalysis, and ECG. • The OS of patients with recurrent or metastatic SCCHN. • The ORR, DOBR, DCR, and DDC of patients with recurrent or metastatic SCCHN using irRECIST evaluated by independent radiology review.
Secondary endpoints. 9.2.2.1 Time from randomization to treatment failure defined as virologic failure (see Section 9.2.1), death, or permanent discontinuation of the NNRTI or PI components of the randomized treatment, whichever occurs first. Changes in the NRTI drugs will not constitute treatment failure. Drug-resistant plasma virus as determined at virologic failure by bulk sequencing.
Secondary endpoints. The secondary endpoints of this clinical trial include:
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. 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. [***] 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. ● 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. 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.
