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Naloxegol Health Outcome Post Authorisation Safety Study

Kyowa Kirin Pharmaceutical Development Ltd · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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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.
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