Regorafenib Post-marketing Surveillance
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer|
- Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
- Number of patients with serious adverse events(SAEs) from the first administration of regorafenib. [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
- Determination of patient's background to affect the safety and efficacy of Regorafenib using standard observational survey and follow-up survey [ Time Frame: baseline ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||March 2021|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Patients treated with Regorafenib under practical manner for colorectal cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843400
|Contact: Bayer Clinical Trials Contactfirstname.lastname@example.org|
|Many Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|