ICH E3 Structure and Content of Clinical Study Reports (cont.)
{"Image DocumentName": "ICH E3 Structure and Content of Clinical Study Reports (cont.)", "Image ImageDescription": "10 Study patients Disposition of patients Protocol deviations. 11. Efficacy evaluation Data sets analyzed Demographic and other baseline characteristics Measurements of treatment compliance Efficacy results and tabulations of individual patient data. 12. Safety evaluation Extent of exposure Adverse events (AEs) 12.3 Deaths, other SAEs, and other significant adverse events Clinical laboratory evaluation Vital signs, physical findings and other observations related to safety Safety conclusions. 11. EFFICACY EVALUATION DATA SETS ANALYSED DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS MEASUREMENTS OF TREATMENT COMPLIANCE EFFICACY RESULTS AND TABULATIONS OF INDIVIDUAL PATIENT DATA Analysis of Efficacy Statistical/Analytical Issues Adjustments for Covariates Handling of Dropouts or Missing Data Interim Analyses and Data Monitoring Multicentre Studies Multiple Comparison/Multiplicity Use of an Efficacy Subset of Patients Active-Control Studies Intended to Show Equivalence Examination of Subgroups Tabulation of Individual Response Data Drug Dose, Drug Concentration, and Relationships to Response Drug-Drug and Drug-Disease Interactions By-Patient Displays Efficacy Conclusions SAFETY EVALUATION EXTENT OF EXPOSURE ADVERSE EVENTS (AES) Brief Summary of Adverse Events Display of Adverse Events Analysis of Adverse Events Listing of Adverse Events by Patient DEATHS, OTHER SERIOUS ADVERSE EVENTS, AND OTHER SIGNIFICANT ADVERSE EVENTS Listing of Deaths, other Serious Adverse Events and Other Significant Adverse Events Deaths Other Serious Adverse Events Other Significant Adverse Events Narratives of Deaths, Other Serious Adverse Events and. Certain Other Significant Adverse Events Analysis and Discussion of Deaths, Other Serious Adverse Events. and Other Significant Adverse Events CLINICAL LABORATORY EVALUATION Listing of Individual Laboratory Measurements by Patient (16.2.8) and Each Abnormal Laboratory Value (14.3.4) Evaluation of Each Laboratory Parameter Laboratory Values Over Time Individual Patient Changes Individual Clinically Significant Abnormalities VITAL SIGNS, PHYSICAL FINDINGS AND OTHER OBSERVATIONS RELATED TO SAFETY SAFETY CONCLUSIONS 27.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}