Vfend Special Investigation For Pediatric - Observational

N/ACompletedNCT02554656

Pfizer89 enrolled

Overview

Examine the safety and effectiveness of Vfend \[voriconazole\] for pediatric under general clinical practices.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pediatric Safety and Effectiveness

Eligibility

Sex: ALLMin age: 0 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who is under 15 years old and deep mycosis infection. Exclusion Criteria: * Patients who have been previously enrolled in this study. -

Locations (1)

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Osaka, Japan

Outcomes

Primary Outcomes

Number of Participants With Adverse Reactions

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician.

Time frame: 16 weeks at maximum

Secondary Outcomes

Number of Participants With Adverse Drug Reactions Not Expected From the LPD (Unknown Adverse Drug Reaction)

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to VFEND was assessed by the physician.

Time frame: 16 weeks at maximum

Incidence of Aadverse Reactions by Diagnosis (Infection)

An ADR was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by diagnosis (infection) to assess whether it was a risk factor for the occurrence of ADRs.

Time frame: 16 weeks at maximum

Overall Clinical Response

Time frame: 16 weeks at maximum

Data from ClinicalTrials.gov

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Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. Overall effectiveness of VFEND was determined by the physician based on the clinical course. Participants achieved clinical effectiveness by Diagnosis (Infection) were counted to assess whether it contributes to the clinical effectiveness.