Validation of a US Health Care Claims Database for the Study of Cardiovascular and Neoplasm Events among Users of Treatments for Overactive Bladder

Study identification

• EU PAS number:
  EUPAS8517
• Study ID:
  30783
• Official title and acronym:
  Validation of a US Health Care Claims Database for the Study of Cardiovascular and Neoplasm Events among Users of Treatments for Overactive Bladder
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Comprehensive Health Insights

Study timelines

Date when funding contract was signed

Actual:01/07/2014

Study start date

Actual:01/10/2014

Date of final study report

Planned:31/07/2015

Actual:15/07/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Global Development

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)