Analysis of Safety Endpoints Sample Clauses

Analysis of Safety Endpoints. ‌ All reported SAEs and AEs will be coded using MedDRA and grouped by body system. SAEs and AEs will be tabulated by treatment group using standard coding terms sorted by body system. The incidence of AEs in each treatment arm will be tabulated by seriousness, severity, and relationship to study drug. If an AE is reported more than once during the study period for a given subject, the greatest severity and the worst-case relationship will be presented in tables. The number of SAEs and AEs will be summarized for each treatment group as follows: (i) The proportion of subjects with at least one (S)AE, (ii) The average number of (S)AEs per patient, and (iii) The rate of (S)AEs per patient week of follow-up. Histograms showing the frequency of the number of (S)AEs in each treatment group will be included. Rates of (S)AEs by System Organ Class (SOC) will be presented by treatment group. Poisson regression modeling will be used to derive rate ratios and 95% CIs for each SOC. The rate ratios will be compared using a two-sided 0.05 level test for Poisson count data. Safety lab data at each study visit and changes from baseline will be summarized by treatment group. In addition, the following clinical laboratory summaries will be presented by treatment group: (i) the incidence of clinically significant abnormalities at each study visit; and (ii) tables summarizing the frequencies of subjects below, within, and above the normal reference ranges at baseline and end of study; and (iii) tables displaying baseline to end of study shifts in each laboratory value (shifts between below, within or above normal range). The proportion of subjects permanently discontinuing study drug will be tabulated by treatment group. Drug discontinuation events will be categorized as: (1) Permanently discontinued study drug and (2) Permanently discontinued study drug and withdrew from study. The reason for permanent drug discontinuation will be summarized. The number of hospitalization events and proportion of subjects hospitalized from baseline to Day 56 will be summarized and compared by treatment group. Poisson regression modeling will be used to derive rate ratios and 95% CIs to compare hospitalization rates between treatment groups.
Sample 1
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Analysis of Safety Endpoints. ‌ All reported treatment emergent SAEs and AEs will be coded using MedDRA and grouped by body system. Treatment emergent AEs are defined as AEs presenting post study treatment initiation. SAEs and AEs will be tabulated by treatment group using standard coding terms sorted by body system. The incidence of AEs in each treatment arm will be tabulated by severity. The number of SAEs and AEs will be summarized for each treatment group as follows: (i) The proportion of subjects with at least one (S)AE, (ii) The average number of (S)AEs per patient, and (iii) The rate of (S)AEs per patient week of follow-up. Histograms showing the frequency of the number of (S)AEs in each treatment group will be included. Rates of (S)AEs by System Organ Class (SOC) will be presented by treatment group. Poisson regression modeling will be used to derive rate ratios and 95% CIs comparing overall S(AE) rates by treatment group as well as within each SOC. The rate ratios will be compared using a two-sided 0.05 level test for Poisson count data. Safety lab data at Visit 2 and Visit 4 and changes from baseline will be summarized by treatment group. In addition, the following clinical laboratory summaries will be presented by treatment group: (i) the incidence of clinically significant abnormalities at each study visit; and (ii) tables summarizing the frequencies of subjects below, within, and above the normal reference ranges at baseline and end of study; and (iii) tables displaying baseline to end of study shifts in each laboratory value (shifts between below, within or above normal range).
Sample 1

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