Safety Endpoints Sample Clauses
Safety Endpoints. Safety will be assessed by evaluation adverse events (AEs)/serious adverse events (SAEs); ▇▇▇▇▇ ▇▇▇▇▇, laboratory parameters (screening, periodically during the study and end of study); electrocardiograms; physical examinations; cognitive function tests using the Cambridge Neuropsychological Test Automated Battery (CANTAB). All subjects will be screened for the presence and severity of depression using the PHQ-9: Modified for Teens (Appendix 4) and for suicidal/ideation using the Columbia Suicide Severity Rating Scale (C-SSRS) (Appendix 5: Sample Columbia Suicide Severity Rating Scale) and follow up assessments will be done at each visit after treatment has been initiated. Bone age (X-ray of the hand and wrist) will be evaluated at baseline and end of study or early termination. Effect on bone mineral density and bone mineral content, as evaluated by Dual-energy X-Ray Absorptiometry (DXA) will be performed at baseline, end of study or early termination, at selected sites.
Safety Endpoints. The safety and tolerability of KPT-9274 ± niacin ER as well as KPT-9274 + nivolumab will be evaluated by means of DLTs, AE reports, physical examination results, electrocardiogram results and laboratory safety evaluations. The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, will be used for grading of AEs. A DLT is defined as an AE or abnormal laboratory value that occurs within the first 28 days of treatment with KPT-9274, except for those that are clearly and incontrovertibly due to underlying disease, disease progression, or extraneous causes, and meets any of the criteria for defining dose- limiting toxicities.
Safety Endpoints. Original text: Amended text:
Safety Endpoints. Safety will be assessed by an evaluation of adverse events, including eye symptoms (collected at each study visit); ***. All subjects will be screened for the *** using a validated survey instrument ***, and for *** using the ***. Follow-up *** assessments will be done at *** after ***.
Safety Endpoints. Safety parameters to be collected and assessed: - Incidence, severity, causality and outcomes of Adverse Events (serious and non-serious), with particular attention being paid to infections - Evolution of laboratory parameters such as complete blood cell count (CBC), with a focus on red cells (haemoglobin), neutrophils and platelets, liver tests, renal function tests and coagulation - Number of patients withdrawn for safety issues • Other parameters: - Level (if any) of circulating antibodies against NI-0501 to determine immunogenicity (ADA) Statistical Analysis: • The primary endpoint Overall Response Rate will be evaluated using the exact binomial test at the one-sided 0.025 level. • Time to Response, durability of Response and Survival time will be presented using ▇▇▇▇▇▇-▇▇▇▇▇ curves with medians calculated if available. 95% confidence intervals will be calculated for the median for each of these endpoints. • Additional endpoints based on binary outcomes including number of patients who reduce glucocorticoids by 50% or more, and number of patients able to proceed to HSCT will be converted to proportions and associated 95% confidence intervals calculated. • Statistical significance in terms of p-values will only be obtained for the primary endpoint. All other endpoints will be viewed as supportive for the primary endpoint and as a consequence no formal hierarchy of endpoints will be declared.
Safety Endpoints. Safety endpoints are: Proportion of subjects experiencing treatment-emergent adverse events (TEAEs), Grade 3 or 4 TEAEs, and serious adverse events (SAEs). Change from baseline in vital sign measurements, 12-lead electrocardiogram (ECG) findings, and clinical laboratory test results. Proportion of subjects experiencing treatment-emergent ophthalmologic abnormalities.
Safety Endpoints. Frequency, intensity, and relationship to study drug of AEs and SAEs, and change from baseline in the following assessments: vital sign measurements, 12-lead ECGs, clinical laboratory measurements, and weight.
Safety Endpoints. Safety endpoints are listed below. • Rates of ocular adverse events, including SSIs related to the optical properties for either eye • Adverse events • Device deficiencies • IOL observations • Subjective PCO • Posterior Capsulotomies
9.1 Outline of Clinical Trial
Safety Endpoints. Safety and tolerability of multiple IV infusions of NI-0501 will be assessed as follows: • Incidence, severity, causality and outcomes of AEs (serious and non-serious), with particular attention being paid to infections • Evolution of laboratory parameters such as complete blood cell count (CBC), with focus on red cells (haemoglobin), neutrophils and platelets, liver tests, renal function tests and coagulation • Number of patients withdrawn for safety issues
Safety Endpoints