This is an observational, multicenter study in participants treated with nivolumab for the approved indications of melanoma and Lung cancer in Australia, the EU, Switzerland, the United Kingdom (UK), and the United States (US). The targeted countries in the EU for study participation include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.
Study Type
OBSERVATIONAL
Enrollment
1,189
Incidence rate of and severity of immune-related pneumonitis - Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related colitis- Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related hepatitis - Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma
Time frame: up to nine years
Incidence rate of and severity of other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Melanoma
Time frame: up to nine years
Incidence rate of and severity of severe infusion reactions- Melanoma
Time frame: up to nine years
Incidence rate of and severity of immune-related pneumonitis - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of immune-related colitis - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of immune-related hepatitis - Lung Cancer
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Local Institution - 1909
Palm Springs, California, United States
Local Institution - 1912
Jacksonville, Florida, United States
Local Institution - 1907
Lake City, Florida, United States
Local Institution - 1901
Park Ridge, Illinois, United States
Local Institution - 1910
Alexandria, Louisiana, United States
Local Institution - 1906
Tupelo, Mississippi, United States
Local Institution - 1908
Kansas City, Missouri, United States
Local Institution - 1911
Morristown, New Jersey, United States
Local Institution - 1902
Bethlehem, Pennsylvania, United States
Local Institution - 1913
Hilton Head Island, South Carolina, United States
...and 84 more locations
Time frame: up to nine years
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of other immune related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of severe infusion reactions - Lung Cancer
Time frame: up to nine years
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer
Time frame: up to nine years
Adverse Events
Other nivolumab treatment-related AEs
Time frame: Up to nine years
Management of Immune-related AEs:
Time frame: Up to nine years
Outcomes of Immune-related AEs:
Time frame: Up to nine years
Overall Survival:
1-, 2-, 3-, 4-, and 5-year overall and median survival
Time frame: Up to nine years
Nivolumab treatment pattern
Time frame: Up to nine years