Vfend Special Investigation For Pediatric - Observational

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

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.

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.

Time frame: 16 weeks at maximum

Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end of the observation period or at the time of treatment discontinuation. The efficacy analysis sets were 74 participants. Participants assessed as indeterminate (n=7) at the final observation were excluded from the calculation.

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

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.

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

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.

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.

Time frame: 16 weeks at maximum

Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end of the observation period or at the time of treatment discontinuation. The efficacy analysis sets were 74 participants. Participants assessed as indeterminate (n=7) at the final observation were excluded from the calculation.