EFFICACY AND SAFETY OF NIVOLUMAB IN RECURRENT OR METASTATIC HEAD AND NECK CANCER (HNC) PATIENTS - JAPANESE REAL-WORLD DATA THROUGH CLINICAL CHART REVIEW
Not Applicable
- Conditions
- HEAD AND NECK CANCER
- Registration Number
- JPRN-UMIN000032600
- Lead Sponsor
- Bristol-Myers Squibb Ono Pharmaceutical CO.,LTD.
- Brief Summary
Refer to the following articles Int J Clin Oncol. 2021 Mar;26(3):494-506. Int J Clin Oncol. 2021 Jun;26(6):1049-1056. Int J Clin Oncol. 2022 Jan;27(1):95-104.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 256
Inclusion Criteria
Not provided
Exclusion Criteria
History of participation in any clinical trials prior- or post-nivolumab treatment
Study & Design
- Study Type
- Others,meta-analysis etc
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Summary statistics for continuous outcomes will include mean, standard deviation, median,inter-quartile range, and range. Summary statistics for categorical or ordinal outcomes will include frequency and percentage. The primary analysis includes a description of actual usage of nivolumab and assessment of effectiveness and safety in which pre-specified immune-related adverse events (irAEs) identified
- Secondary Outcome Measures
Name Time Method