Endpoints. The primary endpoints are occurrence of all adverse events including but not limited to: · all MIs · cardiovascular hospitalization · serious ventricular arrhythmias sustained · VT (symptomatic or sustained VT [duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse] · VF · symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block · symptomatic heart failure (NYHA criteria + physical examination OR hospitalization due to heart failure) · renal failure · stroke · death Secondary Endpoints include the parameters: · 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
Endpoints. The impact of MS and CRP on vascular phenotype in DM2 was assessed using sonographic vascular parameters, IMT, and flow mediated dilatation (FMD), as well as the following en- dothelium-related and hemostatic factors: fibrinogen, s-thrombomodulin (sTM), tissue type plasminogen-activator (tPA), plasminogen-activator inhibitor-1 (PAI-1), sVCAM, sE-selectin, and von Willebrand factor (VWF). Laboratory investigations
Endpoints. The endpoints of this study were differences in inflammatory markers (serum C-reactive protein (CRP) and fibrinogen levels), endothelial function (as estimated using measure- ment of flow mediated dilation (FMD)) and carotid intima-media thickness (CIMT) as a 97 non-invasive measure of atherosclerosis. Furthermore, presence and risk of coronary ath- erosclerosis was assessed using measurement of silent myocardial ischemia (Ambulatory Electrocardiogram(AECG)) and UKPDS risk scores for CVD. Clinical examination Anthropometric measurements were performed by two observers using standardized meth- ods. Waist circumference was measured midway between the iliac crest and the lowest costal margin at the end of normal expiration; hip circumference was measured at the maximal circumference at the level of the femoral trochanters. Blood pressure was measured using a standard sphygmomanometer after a 10 min resting period in supine position. Hypertension was defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. The presence or absence of retinopathy was determined from the subject’s medical files, wherein reports from ophthalmologists were retrieved. Laboratory investigations Lipid and safety measurements were performed at the Department of Clinical Chemistry and Hematology of the Leyenburg Hospital, according to ISO 15189 standard procedures. Blood samples were collected after an overnight fast. A urine sample was collected for the determi- nation of the albumin over creatinine ratio. Serum or plasma was isolated by centrifugation at 2900 rpm for 5 min. Levels of total cholesterol and triglycerides were measured by enzymatic methods on a Synchron LX20-analyzer (Beckman Coulter, Brea, USA). LDL cholesterol was calculated according to the Friedewald formula 13. If triglycerides were > 4.5 mmol/L, LDL cholesterol was measured directly with the use of a reagent kit (Genzyme Diagnostics). HDL cholesterol levels were determined after dextran sulfate-magnesium precipitation of apolipoprotein B-containing lipoproteins. Creatinine kinase and alaninaminotransferase were measured by an enzymatic rate method on a Synchron LX20 multichannel chemistry analyzer, according to IFCCmethods. HbA1c was measured by HPLC on a Variant II (BioRad, USA). For the urine sample, a Jaffe´ rate method was used for the measurement of creatinine on a Synchron LX20- analyzer, while albumin was measured by rate nephelometry. Presence of microalbuminuria was defined a...
Endpoints. (i) Avaya shall use its commercially reasonable efforts to cause (x) the Avaya Endpoints existing as of the Effective Date to be, as soon as reasonably practicable following the Effective Date, and (y) future Avaya Endpoints to be, at all times prior to such Avaya Endpoints being Sold, in each case, compatible with ACO and the other RingCentral Services, and (ii) RingCentral shall use its commercially reasonable efforts to cause (x) the RingCentral Services existing as of the Effective Date to be, as soon as reasonably practicable following the Effective Date, and (y) future RingCentral Services to be, at all times prior to the RingCentral Services being Sold, in each case, compatible with the Avaya Endpoints. To the extent an Avaya Endpoint and the RingCentral Services are so compatible, RingCentral shall offer such Avaya Endpoint as part of its and its Subsidiaries’ product catalogs at least as prominently and positively in the ordinary course of business, in all material respects, as any other RingCentral Offering that is designed to provide substantially similar functionality (taken as a whole) and is then‑currently Marketed in such product catalogs in the ordinary course of business. Each Party acknowledges that the other Party’s performance of its obligations under this Section 2.3(e) depends on such Party’s compliance with this Section 2.3(e) and timely, accurate and effective delivery of all information to make the Avaya Endpoints compatible with ACO, and the other RingCentral Services compatible with the Avaya Endpoints, including such information, cooperation, and assistance reasonably required by either Party. Each Party further acknowledges and agrees that its failure to satisfy any such responsibilities may prevent or delay the other Party’s performance of its obligations under this Section 2.3(e). The Parties agree to work together in good faith to develop a mutually agreed process pursuant to which Avaya will sell to RingCentral certain Avaya Endpoints on commercially favorable terms.
Endpoints. Except as otherwise expressly stated to the contrary in the applicable Cloud Offer Definition or any quotation, Distributor is not responsible for the provision of any end points or similar devices necessary to deploy Cloud Services for any Cloud End User, including personal end points, personal computers, mobile devices and telepresence or room systems.
Endpoints. The incidence and course (timing, location of pain and duration) of myalgia after conditioning were the primary endpoints. Secondary endpoint was pain severity according to the WHO pain relief ladder. Other variables noted above were collected to evaluate potential predisposing factors. Statistical analysis Descriptive statistics, such as median and frequency, were used to summarize baseline characteristics and outcomes. Odds ratios (OR) were estimated by means of logistic regression to examine the association between conditioning regimen (TREO-based vs. BU-based) and myalgia and adjusted for possible confounding (hemoglobinopathies versus other indications). In the TREO cohort, univariable and multivariable logistic regression was performed to assess whether baseline- or transplant characteristics (age, underlying disease, conditioning regimen, treosulfan exposure) were prognostic for the development of myalgia. All P-values were 2-tailed and considered significant when P<0.05. Statistical 5 analyses were performed using R version 3.6.1 and RStudio version 1.2.5019.
Endpoints. Except as otherwise expressly stated to the contrary in the applicable Cloud Offer Definition or Avaya’s quotation, Avaya is not responsible for the provision of any end points or similar devices necessary to deploy Cloud Services for any Reseller or Cloud End User, including personal end points, personal computers, mobile devices and telepresence or room systems. 4.9.
Endpoints. Safety will be assessed as follows: - The incidence, seriousness, intensity, possible relationship to NI-0501 and outcomes of AEs. - Evaluation over time of xxxxx xxxxx, physical examination and laboratory values: evolution over time. • Efficacy (as relevant, depending on the different patients’ characteristics): - Duration of Response after completion of NI-0501 treatment (assessed according to the definitions set in the parent study) - Survival time up to one year post-HSCT (including survival to HSCT and survival post-HSCT) or one year after last NI-0501 infusion (if transplant is not performed) - Post-HSCT outcome indices, e.g. engraftment rate, donor chimerism achieved, incidence of acute and chronic Graft versus Host Disease (GvHD) (it applies to patients who receive HSCT) - Monitoring of background disease activity (it applies to patients with secondary forms of HLH) • Pharmacokinetics:
Endpoints. Primary Endpoint Progression-Free Survival (PFS) Secondary Endpoints Overall Survival (OS) Confidential material omitted and filed separately with the Commission. CONFIDENTIAL EXECUTION VERSION Safety and Tolerability Pharmacokinetics Exploratory Endpoints Biomarkers (as predictors of response) Exploratory Imaging Neurological and Behavioural Instruments (MDASI-BT, neuro-cognitive tests, etc.) Quality of Life (HRQoL)
Endpoints. Full anatomical, clinical path, hematology, clinical chem, histopath; also, toxicokinetics - In order to initiate carcinogenicity studies within the timeline for CAA submission, we have included a three-month sacrifice group as a dose-ranging fror the rat carcinogenicity studies
