LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)
- Conditions
- Pancreatic Neoplasms
- Registration Number
- NCT04889404
- Lead Sponsor
- AstraZeneca
- Brief Summary
To collect and characterise the incidence of adverse events related to the safety specifications of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.
- Detailed Description
To collect and characterise the incidence of adverse events related to the safety specifications\*1 of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.
This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.
\*1: Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- Patients who receive LYNPARZA for the first time for the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated curatively unresectable pancreas cancer after the approval date of partial change application for the additional indication (25/Dec./2020).
- Patients who have no treatment history with LYNPARZA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events related to the safety specifications from baseline to 1year Safety specifications:Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇯🇵Yamagata, Japan