An Observational Post-Authorisation Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Treated With Opioids Chronically

D3820R00009

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.

2016-09-01

2021-11-01

2021-11-01

Terminated

10000

Inclusion Criteria: 1. Patient receives a new prescription for naloxegol or a non-PAMORA laxative. (Note: Only non-PAMORA laxatives that are approved/marketed in the European Union at the time naloxegol is authorized are permitted.) Exclusion Criteria: 1. Patients \<18 years of age on cohort entry date 2. Patients with \<1 year of continuous data available prior to cohort entry date 3. Patients without exposure to current regular opioid use defined by \>30 days of opioid exposure within the 180 days prior to and inclusive of the cohort entry date 4. Patients with evidence of a cancer indicator (diagnosis or treatment) prior to cohort entry date 5. Exposure to PAMORA laxatives, alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations) prior to cohort entry date

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 10000, 'type': 'ACTUAL'}}

2024-02-23