An Open-Label, Multi-Centre, Non-Interventional, Post-Marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Votrient Administered in Korean Patients According to the Prescribing Information (115578)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20900
• EU PAS number:
  EUPAS5153
• Study ID:
  20900
• Official title and acronym:
  An Open-Label, Multi-Centre, Non-Interventional, Post-Marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Votrient Administered in Korean Patients According to the Prescribing Information (115578)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  Non-Interventional, Open-Label, Single Group, Multicentric Post-Marketing Surveillance to Monitor the Safety and Effectiveness of Pazopanib Administered in Korean Patients According to the Prescribing Information
• Study status:
  Finalised

Research institution and networks

Institutions

Novartis Pharmaceuticals

Asan Medical Center Seoul, Korea

Study timelines

Date when funding contract was signed

Planned: 26/01/2012

Actual: 26/01/2012

Study start date

Planned: 21/02/2012

Actual: 21/02/2012

Date of final study report

Planned: 31/12/2017

Actual: 24/08/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Study protocol

Initial protocol

115578 Protocol_GSK

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)