Unresectable malignant melanoma /Unresectable,advanced or recurrent Non-Small Cell Lung Cancer /Unresectable or metastatic renal cell cancer /Recurrent or distant metastatic head and neck cancer /Unresectable advanced or recurrent gastric/gastroesophageal junction cancer that has progressed after chemotherapy
Conditions
Interventions
None listed
Sponsors
Ono Pharmaceutical Co., Ltd. Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In the post marketing survey of nivolumab for each of the following cancer types, patients who met the criteria for safety analysis among the population in which fixed CRFs were collected. /Unresectable malignant melanoma /Unresectable,advanced or recurrent NSCLC /Unresectable or metastatic renal cell cancer /Recurrent or distant metastatic head and neck cancer /Unresectable advanced or recurrent gastric/gastroesophageal junction cancer that has progressed after chemotherapy
Exclusion criteria
Exclusion criteria: Of the patients who met the criteria for the safety analysis set, those for whom the site approval was not obtained for the use of PMS data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile of Nivolumab in patients with various complications/past history (autoimmune disease, tuberculosis, hepatitis B, hepatitis C), elderly patients, and vaccinated patients (incidence of adverse events, incidence of special interest, time of onset, etc.)Risk factors for the development of irAEs with a high risk of becoming serious | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile in the overall population"incidence of adverse events,incidence of adverse event of special interest,time of onset, etc."/Risk factors for recurrence/aggravation of various complications/past histories"autoimmune disease,tuberculosis,hepatitisB,hepatitis C"Safety profile in each autoimmune disease"number of events,number of events of Grade3 or more and outcome" | — |
Countries
Japan
Contacts
Public ContactKenji Hiraizumi
Ono Pharmaceutical Co., Ltd. Oncology Medical , Medical Affairs
Outcome results
None listed