Stopped: Not feasible to reach the required number of patient cases by the defined end of data collection milestone (Q4 2022) knowing that the study completion was planned by the end of 2023
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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Presence (yes/no) of bowel perforation
Timeframe: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence (yes/no) of acute MI
Timeframe: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence (yes/no) of stroke
Timeframe: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence (yes/no) of all-cause mortality
Timeframe: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence (yes/no) of hypertension
Timeframe: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years