Prospective international observational cohort non-comparative study describing the safety and effectiveness of ZALTRAP® administered in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer in current clinical practice: A Post-Authorisation Safety Study (PASS) (OZONE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34370
• EU PAS number:
  EUPAS4836
• Study ID:
  34370
• Official title and acronym:
  Prospective international observational cohort non-comparative study describing the safety and effectiveness of ZALTRAP® administered in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer in current clinical practice: A Post-Authorisation Safety Study (PASS) (OZONE)
• DARWIN EU® study:
  No
• Study countries:
  Finland

  France

  Germany

  Greece

  Italy

  Puerto Rico

  Slovakia

  Spain

  Sweden

  Switzerland

  United Kingdom

  United States
• Study description:
  This is an observational study designed to follow patients with metastatic CRC who are receiving Zaltrap in combination with FOLFIRI.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned: 12/04/2013

Actual: 12/04/2013

Study start date

Planned: 08/10/2013

Actual: 08/10/2013

Date of final study report

Planned: 11/08/2018

Actual: 04/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

SANOFI

Study protocol

Initial protocol

obs13597-16-1-1-protocol-20130701

Updated protocol

obs13597-amended-protocol02

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)