Clinical Trial: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Post Marketing Surveillance Study To Observe Safety And Effectiveness Of Eraxis (Registered) Iv.

Brief Summary: The objective of this study is to collect the safety and efficacy data of Eraxis IV (anidulafungin) 100 mg according to Korea Ministry of Food and Drug Safety regulations.

Detailed Summary:

The objective of this study is to determine any problems or questions associated with Eraxis after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination guideline of new drugs".

  1. Serious adverse event/adverse drug reaction
  2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
  3. Known adverse drug reaction
  4. Non-serious adverse drug reaction
  5. Other safety and effectiveness information

Eraxis was first approved as new medicine on 30 May 2008. As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), safety and effectiveness information of new medication should have been provided certain number of subjects administered in the setting of routine practice during the initial 6 years after the approval (until 29 May 2014). However, all required subject had not enrolled during the original reexamination period (30 May 2008 ~ 29 May 2014). Therefore, according to an order from MFDS in 02 Mar 2015, Eraxis PMS was required to collect rest of all required subjects by 02 September 2016 in prospective and restrospective approach.


Sponsor: Pfizer

Current Primary Outcome:

  • Endpoint on Final efficacy. - Clinical response - Mycological response - Overall response (consisting of a combination of both clinical and mycological response). [ Time Frame: over the study period ]
  • Endpoint on Safety. - Incidence of adverse event. - Others, abnormal finding from laboratory test (if any). [ Time Frame: over the study period ]


Original Primary Outcome:

  • Endpoint on Final efficacy. - Mycological outcome. - Global response (consisting of a combination of both clinical and mycological response). [ Time Frame: over the study period ]
  • Endpoint on Safety. - Incidence of adverse event. - Others, abnormal finding from laboratory test (if any). [ Time Frame: through the study period ]


Current Secondary Outcome:

  • Unexpected adverse event (especially, occurrence of serious adverse events). [ Time Frame: over the study period ]
  • The circumstantial factor of adverse event appearing under after maintained certain drug. [ Time Frame: over the study period ]
  • Factors affecting safety. [ Time Frame: over the study period ]
  • Factors affecting efficacy. [ Time Frame: over the study period ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: December 3, 2008
Date Started: March 2012
Date Completion:
Last Updated: July 11, 2016
Last Verified: July 2016