Naloxegol Health Outcome Post Authorisation Safety Study
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This post-authorization observational safety study (PASS) monitors clinically important
identified and potential risks within a cohort of patients treated with naloxegol, including
the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular
(CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal
pain, diarrhea, syncope, and change in pain severity. This study is part of a broader
post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in
clinical practice.
Details
Lead Sponsor:
AstraZeneca Kyowa Kirin Pharmaceutical Development Ltd