Overview
To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.
Description
The AU-011-404 study complements the AU-011-301 clinical trial, and aims to identify the broader impact of bel-sar treatment on subjects' daily lives and overall well-being through the collection of PROs. This noninterventional PRO study will provide valuable insights of treatment impact by capturing real-world perspective on aspects including symptom management, functional status, and overall health-related quality of life (QoL).
The sites will direct interested participants to the study via a unique URL. Upon accessing the URL, participants will be asked to complete screening questions to confirm their eligibility and review/sign an informed consent document (ICD). Eligible participants will then be asked to complete custom survey questions and the EORTC QLQ-OPT30 questionnaire for up to 24 months.
Eligibility
Inclusion Criteria:
- Have enrolled in the Aura-sponsored clinical trial AU-011-301.
- Access to a connected device (i.e., smartphone, laptop, or tablet)
Exclusion Criteria:
- None