Safety Analysis. The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and SAEs will be identified. Individual subject listings will be provided, as necessary. Individual subject listings will be provided for AEs that occur after signing informed consent but prior to exposure to study lenses. Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from baseline (Visit 2 or Visit 1, if Visit 2 and Visit 1 occur on the same date) to any subsequent visit will be presented. A supportive listing will be generated which will include all biomicroscopy data from all visits for these eyes experiencing the increase. Two listings (prior to exposure of study lenses and treatment-emergent) of device deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each device deficiency category will be tabulated. No inferential testing will be done for safety analysis.
Safety Analysis. Data will be summarized and tabulated based on the enrolled population for this Extension Study. All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs. · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable. Safety assessments for changes in physical examination, xxxxx xxxxx, ECG, and laboratory tests will be descriptively summarized by treatment and study periods. Concomitant medication classes will be categorized using World Health Organization (WHO) drug dictionary and summarized by number and percent of subjects using each class by treatment group. All treatment emergent adverse events (TEAEs) will be coded for system organ class (SOC) and preferred term (PT) using MedDRA and the number (%) of subjects experiencing each AE (SOC/PT) will be summarized by treatment, relationship to treatment, and severity. All serious adverse events (SAE) will be listed and the number (%) of subjects with an SAE presented by treatment group. Similar safety analyses will be conducted cumulatively at Months 12, 18, and 24 (i.e., Visits 4, 5, and 6). Full details of these analyses will be provided in the Statistical Analysis Plan.
Safety Analysis. Data will be summarized and tabulated based on the enrolled population for this Extension Study. All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs; · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable; Safety assessments for changes in physical examination, xxxxx xxxxx, ECG, and laboratory tests will be descriptively summarized by treatment and study periods. The results of anti-BA058 testing will be summarized. Concomitant medication classes will be categorized using World Health Organization (WHO) drug dictionary and summarized by number and percent of subjects using each class by treatment group. All treatment emergent adverse events (TEAEs) will be coded for system organ class (SOC) and preferred term (PT) using MedDRA and the number (%) of subjects experiencing each AE (SOC/PT) will be summarized by treatment, relationship to treatment, and severity. All serious adverse events (SAE) will be listed and the number (%) of subjects with an SAE presented by treatment group. Similar safety analyses will be conducted cumulatively at Months 12, 18, and 24 (i.e., Visits 4, 5, and 6). Full details of these analyses will be provided in the Statistical Analysis Plan.
Safety Analysis. The CONSULTANT will perform predictive safety analysis in accordance with the Highway Safety Manual (HSM)
Safety Analysis. Data will be summarized and tabulated based on the enrolled population for this Extension Study. All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs. · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable. Safety assessments for changes in physical examination, xxxxx xxxxx, ECG, and laboratory tests will be descriptively summarized by treatment and study periods. Concomitant medication classes will be categorized using World Health Organization (WHO) drug dictionary and summarized by number and percent of subjects using each class by treatment group. All treatment emergent adverse events (TEAEs) will be coded for system organ class (SOC) and preferred term (PT) using MedDRA and the number (%) of subjects experiencing each AE (SOC/PT) will be summarized by treatment, relationship to treatment, and severity. All serious adverse events (SAE) will be listed and the number (%) of subjects with an SAE presented by treatment group.
Safety Analysis. Transcend shall conduct detailed crash analysis for the 20 roadway segments and 20 intersections. Based on identified safety issues, we anticipate that up to 5 of these locations may need Road Safety Audit (RSA)s before countermeasures can be recommended. Average crash rates shall be developed to compare with statewide averages. Using FHWA’s Clearinghouse, countermeasures such as turn lanes, median installation, minor geometric modifications, lighting, speed control and signal phasing/timing adjustments will be identified for the prioritized list of locations.
Safety Analysis. The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. All AEs occurring from the time a subject signs informed consent to study exit will be accounted for in the reporting. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and SAEs will be identified. Individual subject listings will be provided, as necessary. No inferential testing will be done for safety analysis.
Safety Analysis. Two general types of safety implications are associated with the Seattle/LWC UPA projects. First, the Active Traffic Management elements to be deployed on SR 520 and I-90 are intended to reduce the number of crashes on those facilities. The intent is to reduce crashes by posting variable speed limits on the ATM gantry-mounted signs that will warn drivers of backups ahead and smooth out traffic as it approaches a lane block incident. WSDOT also intends to use the ATM signs to quickly close entire lanes and provide warning information to drivers before they reach slower traffic13. The second safety implication is that the introduction of the new signage related to tolling, ATM and travel times may impact safety in the first few weeks after deployment as drivers become accustomed to the new information and react to it by changing lanes and/or speeds. Table 4-10 presents the safety hypotheses, XXXx and data for the safety analysis. XXXx focus on the percent change in crash rate by type and severity, the percent change in the average duration of incidents (ATM is expected to reduce the amount of incident-related congestion, thus speeding recovery to pre-incident traffic flow conditions), and the change in the perception of safety by enforcement, WSDOT Incident Response Team (IRT), and first response personnel, as well as bus operators. Data needed to assess these XXXx include the number of crashes by type and severity and the number and duration of incidents. Information on changes in the perception of safety will be obtained through surveys and interviews with IRT members, state patrol officers, medical first responders, and bus operators. The safety test plan summary presents additional information on the data sources and analysis techniques. A number of issues may need consideration in assessing the safety impacts of the Seattle/LWC UPA projects. First is the possible influence of other factors such as the introduction of new non-UPA projects, construction, and major weather events. Second, it may be difficult to detect significant changes in safety impacts in the one-year post-deployment period, especially since the a multi-month lag in crash data availability means that the post-deployment period will include only about 10 months of data. Finally, it may not be possible to link the cause of a crash to a specific UPA project element. To the extent that these challenges compromise the ability to draw conclusions based strictly on quantitative data, the quali...
Safety Analysis. Data will be summarized and tabulated based on the enrolled population for this Extension Study. All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs; · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable; Safety assessments for changes in physical examination, xxxxx xxxxx, ECG, and laboratory tests will be descriptively summarized by treatment and study periods. The results of anti- BA058 testing will be summarized. Concomitant medication classes will be categorized using World Health Organization (WHO) drug dictionary and summarized by number and percent of subjects using each class by treatment group. All treatment emergent adverse events (TEAEs) will be coded for system organ class (SOC) and preferred term (PT) using MedDRA and the number (%) of subjects experiencing each AE (SOC/PT) will be summarized by treatment, relationship to treatment, and severity. All serious adverse events (SAE) will be listed and the number (%) of subjects with an SAE presented by treatment group.
Safety Analysis. Conduct a high-level safety review of intersections within the study area to identify crash trends and locations for further investigation. It is assumed up to 8 intersections with the highest crash frequency will include a more detailed review to identify crash trends and potential issues for presentation to the Study Advisory Team.
