The Clinical Study Safety demo helps site managers, clinical statisticians, and trial overseers to spot trends, identify issues, and make informed decisions throughout the clinical trial process. This helps detect issues early and make necessary adjustments to improve the chances of FDA approval.The dataset is on xanomeline. Xanomeline is used to treat neurological symptoms such as schizophrenia. The dataset tracks patients over the course of their treatment. It was used originally in a pilot study for developing CDISC ADaM standards, which are guidelines for submitting clinical trial safety data to the FDA. We use Spotfire for analyzing the following:

Demographics , Disposition Events: Details on the patients’ backgrounds split by treatment group

Adverse events , Relative Risk: Records of any negative symptoms and relative risk assessment

Lab Safety Ranges , Lab Changes from Baseline (1), Lab Changes from Baseline (2) , Hepatotoxicity: Information on lab test readings throughout the trial, changes from baseline, hepatotoxicity warnings

Patient Profile: A consolidated view of individual patient journeys through the study

Learn more from this community article