MedPath

ZALTRAP Special Drug Use Surveillance (Unresectable advanced and/or recurrent colorectal cancer)

Not Applicable
Conditions
colorectal cancer
Registration Number
JPRN-UMIN000028897
Lead Sponsor
Sanofi K.K.
Brief Summary

The incidence of adverse reactions in this study was lower than that occurred at the time of approval of the drug.The benefit-risk assessment of Zaltrap in this study was favorable and it was judged that there was no additional safety concerns identified.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
261
Inclusion Criteria

Not provided

Exclusion Criteria

Patients concurrently participating in any interventional clinical studies

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety: Incidence rate of adverse drug reaction Effectiveness: Tumor assessment
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath