Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.
Study Type
OBSERVATIONAL
Enrollment
1,014
Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie \[mCi\]) every 8 weeks for a total of 4 doses.
Banner MD Anderson Cancer Center
Phoenix, Arizona, United States
The Ohio State University Wexner Medical Center
Portland, Ohio, United States
secondary cancers: incidence of secondary cancers
incidence of secondary cancers
Time frame: up to 7 years follow-up
safety profile: incidence of adverse events
incidence of adverse events
Time frame: up to 7 years follow-up
mortality
mortality (all cause)
Time frame: up to 7 years follow-up
LUTATHERA dose per administration
average dose per administration
Time frame: completion of treatment phase (approximately 2 years total)
LUTATHERA total dose
average total dose administered
Time frame: completion of treatment phase (approximately 2 years total)
LUTATHERA number of administrations
average number of LUTATHERA doses
Time frame: completion of treatment phase (approximately 2 years total)
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Oregon Health & Sciences University Hospital
Portland, Oregon, United States
Virginia Mason in Seattle
Seattle, Washington, United States
Novartis Investigative site
Clichy, France
Novartis Investigative site
Lyon, France
Novartis Investigative site
Villejuif, France
Novartis Investigative site
Coimbra, Coimbra District, Portugal
Novartis Investigative site
Santiago de Compostela, La Corunya, Spain
Novartis Investigative site
Majadahonda, Madrid, Spain
...and 10 more locations