Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)
- Registration Number
- NCT01436578
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will examine the safety and efficacy of posaconazole in general use in Korea.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 273
Inclusion Criteria
- Treated with posaconazole oral suspension within current local label
Exclusion Criteria
- Contraindication to posaconazole oral suspension according to current local label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All Participants Posaconazole oral suspension 40 mg/mL All participants treated with posaconazole oral suspension during the pre-specified surveillance period.
- Primary Outcome Measures
Name Time Method Number of participants with unexpected drug-related adverse experiences During treatment and for 30 days following cessation of treatment Number of Participants with Responses of Improved, Not Improved, and Worsened After at least 14 days of treatment Number of participants with Serious Adverse Experiences During treatment and for 30 days following cessation of treatment Number of participants with drug-related adverse experiences During treatment and for 30 days following cessation of treatment Number of participants with Non-Serious Adverse Experiences During treatment and for 30 days following cessation of treatment
- Secondary Outcome Measures
Name Time Method