A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents (MYCOS)

Study identification

• EU PAS number:
  EUPAS2857
• Study ID:
  35221
• Official title and acronym:
  A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents (MYCOS)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with follow-up until 2016.
• Study status:
  Finalised

Research institutions and networks

Institutions

World Health Information Science Consultants, LLC (WHISCON)

Brigham and Women's Hospital and Massachusetts General Hospital MA, USA, Hospital of the University of Pennsylvania PA, USA, University of Pittsburgh Medical Center PA, USA, Duke University Medical Center NC, USA, University of Michigan Hospitals and Health Systems MI, USA, Johns Hopkins University MD, USA

Study timelines

Date when funding contract was signed

Planned: 23/05/2011

Actual: 23/05/2011

Study start date

Planned: 20/09/2012

Actual: 20/09/2012

Data analysis start date

Planned: 01/10/2012

Actual: 01/10/2012

Date of interim report, if expected

Planned: 30/06/2014

Actual: 30/06/2014

Date of final study report

Planned: 30/11/2020

Actual: 05/11/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)

Other study registration identification numbers and links

ISN 9463-CL-1401