MedPath

KADCYLA drug use surveillance

Not Applicable
Conditions
Breast cancer
Registration Number
JPRN-UMIN000017702
Lead Sponsor
Chugai Pharmaceutical Co., Ltd.
Brief Summary

The adverse drug reaction incidence rate in 250 examples of safety analysis was 69.60% (174/ 250 example), and the case number was 438, and platelet decreased number 54.40% (136/250 examples), aspartic acid AMINOTORANSUFERAZE increased 31.20 % (78/250 examples), ARANINAMINOTORANSUFERAZE increased 20.00 % (50/250 examples), liver function abnormal 8.00 % (20/250 examples) and nose bleeding 6.80 % (17/250 examples) met main adverse drug reactions (5% or more than of adverse drug reaction incidence rate).

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
250
Inclusion Criteria

Not provided

Exclusion Criteria

No criteria

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath