Vfend Special Investigation For Prophylaxis

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.

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.

An adverse drug reaction (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 age (<15 years, ≥15 years) to assess whether it was a risk factor for the occurrence of ADRs.

An adverse drug reaction (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 reason for use to assess whether it was a risk factor for the occurrence of ADRs.

An adverse drug reaction (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 long-term use to assess whether it was a risk factor for the occurrence of ADRs.

IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate.

IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by age (<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.

IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.

Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate.

Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by age (<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.

Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.