A Survey of Experiences and Opinions Regarding Skin Toxicities Associated with Vectibix Among mCRC Patients

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38009
• EU PAS number:
  EUPAS30334
• Study ID:
  38009
• Official title and acronym:
  A Survey of Experiences and Opinions Regarding Skin Toxicities Associated with Vectibix Among mCRC Patients
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This descriptive study is designed with the primary objective of assessing experiences and opinions regarding dermatologic toxicities that may develop among mCRC patients who are treated with and without Vectibix.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 01/03/2019

Actual: 15/03/2019

Study start date

Planned: 01/11/2019

Actual: 01/11/2019

Data analysis start date

Planned: 01/01/2020

Actual: 15/11/2019

Date of final study report

Planned: 30/06/2020

Actual: 11/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

csr-20190025-protocol_public-redacted-approved-version

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable