This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer. The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice. A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.
Study Type
OBSERVATIONAL
Enrollment
1,301
Patients treated with Regorafenib under practical manner for colorectal cancer.
Unnamed facility
Multiple Locations, Japan
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib
Time frame: Up to 6 months
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
Time frame: up to 6 months
Number of pateints with ADRs in subpopulations
Time frame: Up to 6 months
Number of patients with SAEs in supopulations
Time frame: Up to 6 months
Overall survival (OS)
Time frame: Up to 12 months
Overall survival in subpopulations
Time frame: Up to 12 months
Time to treatment failure (TTF)
Time frame: Up to 12 months
Time to Treatment failure in subpopulations
Time frame: Up to 12 months
Tumor response assessed by RECIST or physicians own evaluation
RECIST: Response Evaluation Criteria In Solid Tumors
Time frame: Up to 6 months
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