Integrated Analysis of Post Marketing Survey for Nivolumab
Not Applicable
- Conditions
- nresectable 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
- Registration Number
- JPRN-UMIN000048892
- Lead Sponsor
- Ono Pharmaceutical Co., Ltd. Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 7421
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Others,meta-analysis etc
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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"