ProAE

ProAE implements standardized statistical analysis and graphical representation of patient-reported outcomes and adverse events data, specifically focusing on PRO-CTCAE.

Key Features:

• Hypothesis Testing: Provides standardized statistical hypothesis testing for PRO-CTCAE and other PRO data.
• Descriptive and Inferential Tables: Generates descriptive and inferential summary tables for patient-reported outcomes and adverse events.
• Longitudinal Graphics: Produces longitudinal graphical displays for tracking patient-reported symptomatic adverse events over time.
• R Package and SAS Macros: Offers functionality through both an R package and a collection of SAS macros.

Scientific Applications:

• Oncology Clinical Trials: Supports analysis of patient-reported symptomatic adverse events to characterize treatment tolerability and inform clinical decision making.
• PRO-CTCAE Data Analysis: Enables standardized reporting and graphical approaches for the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events.
• Treatment Tolerability Research: Facilitates research on cancer treatment tolerability through unified analysis methods.

Methodology:

Testing and validation of widely used methods were implemented in the R package.