Safety Analyses Sample Clauses

Safety Analyses. Safety analyses will be performed using the Safety Analysis Set.

Safety Analyses. The safety endpoints are: • AEs • Biomicroscopy Findings • Device Deficiencies There are no safety hypotheses planned in this study. The focus of the safety analysis will be a comprehensive descriptive assessment of occurrence of AE as well as the other listed parameters. All AEs occurring from the time a subject signs informed consent to study exit will be accounted for in the reporting. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 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 IP. Two listings for device deficiencies, prior to exposure of study contact lenses and treatment- emergent, will be provided. Additionally, each device deficiency category will be tabulated. No inferential testing will be done for safety analysis.

Safety Analyses. Adverse events will be coded by preferred term and system organ class using the latest version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, as well as by severity and relationship to study drug. Serious AEs and AEs leading to discontinuation of study drug will also be presented in the data listings and summarized overall. Actual values and changes from baseline for clinical laboratory test results, vital sign measurements, and 12-lead ECG results will be summarized at each time point using descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital sign measurements, 12-lead ECG results, and physical examination findings will be presented in data listings.

Safety Analyses. ‌ Safety analyses will be based on the reported AEs and other clinical information. Safety analyses will be performed in AT population. The safety and tolerability of selinexor will be evaluated by means of drug-related AE reports, physical examinations, and laboratory safety evaluations. The grading of the severity of the AEs will be done according to CTCAE, v.5.0. Investigators will provide their assessment as either the AE is related or not related to study drug. Treatment-emergent AEs, SAEs, AEs of at least Grade 3 in severity, related AEs, and AEs leading to withdrawal of treatment will be summarized by cohort and in the overall safety population. Treatment-emergent AEs will be those that start or worsen on or after the first day of study treatment, through 30 days after last dose. Related AEs will be those with an Investigator determination of related to study drug. 9.4.3. Pharmacokinetic Analysis‌ Plasma samples will be analyzed via a validated HPLC/MS-MS method for plasma selinexor concentration. Selinexor Cmax and Ctrough data will be summarized. Selinexor concentration data might also be analyzed using a population PK modeling approach if deemed necessary. Details of the population PK analysis, including software, post-processing and statistical analysis, will be outlined in a separate Data Analysis Plan to be completed prior to database lock. 9.4.4. Pharmacodynamic Analysis‌ Plasma proteins will be assessed and quantified by immunoassays and multiplex assays when possible in a central lab. 9.4.5. Viral Analysis‌ Viral testing will be assessed and quantified.

Safety Analyses. Treatment emergent adverse events (TEAEs) will be summarized by system organ class (SOC) and preferred term (PT). Non-emergent events will be recorded in the data listings. For all AE tables, the number and percentage of patients reporting AEs will be grouped by the Medical Dictionary for Regulatory Activities (MedDRA) SOC and PT. Descriptive statistics for ECG, ECHO, ▇▇▇▇▇ ▇▇▇▇▇, and clinical laboratory parameters will be generated. Summary statistics for each parameter at the specific visits, as well as the change from Baseline to that visit, will also be displayed. All safety data will be presented in data listings. CCI Sarepta Therapeutics, Inc. Study 4658-204 Page 10 of 55 Functional assessments, CCI , ECG, ▇▇▇▇▇▇ ECG, and ECHO have a ±2 weeks window a For infusion visits, ▇▇▇▇▇ ▇▇▇▇▇ are to be collected within approximately 30 minutes prior to infusion and approximately 5, 30, and 60 minutes after the end of the infusion. If the patient has not experienced an infusion reaction after the first year of treatment, ▇▇▇▇▇ ▇▇▇▇▇ may be collected only 30 minutes after the end of the infusion. b Blood samples for the safety laboratory assessments must be obtained within 2 weeks prior to the Baseline/Week 1 visit, and results must be available prior to dosing at Baseline/Week 1. If more than 2 weeks have elapsed since the collection of blood samples for the Screening safety laboratory assessments, it must be repeated. If less than 2 weeks have elapsed since the collection of blood samples for the Screening safety laboratory assessments, additional safety laboratory assessments do not need to be performed. c Patients may start dosing based on local genotyping results provided that these results fulfill the required inclusion criteria; however, all patients must undergo genetic testing to confirm the exon 51 skippable mutation and CCI . C

Safety Analyses. Safety analyses will be performed using the Safety Population. Safety and tolerability will be assessed by: • Incidence of AEs and SAEs throughout the entire duration of the study • Incidence of AEs associated with abuse liability using the MADDERS® • Assessment of physical examination findings • Changes from baseline (Visit 2) in ECG results • Changes from baseline (Visit 2) in clinical laboratory test results • Changes from baseline (Visit 2) in vital signs and weight • Indications of increased suicidal ideation or behavior as assessed by the C-SSRS • Changes from baseline (Visit 2) in patient-rated CSFQ-14 in males and in females, assessed separately • Change from baseline Visit 5 or End of Treatment) in the SOWS at the safety follow-up visit Adverse events will be coded using MedDRA and will be summarized overall and by preferred term and system organ class. Adverse events will also be summarized by severity and relationship to study drug. Serious AEs and AEs leading to discontinuation of study drug will also be summarized. Actual values and changes from baseline for responses on the CSFQ-14, and actual values and changes from baseline in clinical laboratory test results, ECG parameters, vital signs, and weight will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). AEs associated with abuse liability of the study drug will be evaluated using the MADDERS®. Withdrawal symptoms associated with the study drug after the End of Treatment (Visit 5/ET) will be evaluated using the SOWS. The number of patients with suicidal behaviors, ideations and acts based on the C-SSRS will be tabulated by treatment group and listed. Physical examination data will be presented in data listings.

Safety Analyses. All safety summaries and analyses will be based upon the Safety Population as defined in Section 13.1. Overall exposure to study drug, the numbers of patients completing each cycle, and the will be summarized using descriptive statistics. An overall summary of AEs will be provided for AEs deemed by the investigator to be possibly related to study drug, and for all causalities. A treatment-emergent adverse event (TEAE) is defined as an event that first occurred or worsened in severity after baseline. The number of patients who experienced a TEAE, SAE, TEAE related to study drug, died, or discontinued from the study due to an AE will be summarized by treatment. Common Terminology Criteria for Adverse Events v 5.0 will be used when reporting AEs by CTCAE terms. Laboratory and non-laboratory CTCAEs will be summarized by CTCAE term and maximum CTCAE grade, including the total for maximum Grade 3 and 4. These summaries will be provided for events regardless of study drug causality, and for events deemed by the investigator to be possibly related to study medication. Reasons for death will be summarized separately for on-therapy and within 30 days of last dose of study drug. Serious adverse events will be summarized by PT. Hospitalizations and transfusions during the study treatment period or during the 30-day follow-up period will be summarized by treatment group.

Safety Analyses. The safety endpoints are: • AEs • Biomicroscopy Findings • Device Deficiencies There are no safety hypotheses planned in this study. The focus of the safety analysis will be a comprehensive descriptive assessment of occurrence of AE as well as the other listed parameters. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms, for Completed and Discontinued sets. A listing containing details of the AEs will also be provided.

Safety Analyses. All safety analyses will be made on the Safety Set. Safety analyses will include all AEs, ECGs, clinical laboratory data, physical examinations, and vital sign measurements using descriptive statistics. No inferential statistical analyses are planned for the safety parameters of this study. The incidence of AEs and SAEs will be summarized by System Organ Class and Preferred Term for each treatment and overall, and by relationship to study intervention. Adverse events will also be summarized by treatment and overall by severity. Serious AEs and AEs resulting in withdrawal from the study will be listed. Participants having multiple AEs within a category (eg, overall, System Organ Class, Preferred Term) will be counted once in that category. For severity tables, a participant’s most severe event within a category will be counted. Changes from baseline in vital sign measurements and laboratory assessments (eg, chemistry, blood cell count with differential, and urinalysis) will be summarized by treatment. Laboratory parameter values will be graded according to the National Cancer Institute CTCAE. Shift tables by treatment will be produced for these laboratory parameters. These tables will summarize the number of participants with each baseline grade relative to the reference ranges and changes to the worst highest grade assessed post-dose during the study. ECG parameters will be measured at the specified time points as per the SoA (Table 1), including heart rate, PR, RR, QRS, QT, and QTcF intervals. The average of the triplicate ECG readings at the time points collected will be calculated, and changes from pretreatment baseline values will be assessed by each treatment. All concomitant medications will be coded and summarized using the World Health Organization (WHO) Drug Dictionary.