Safety of XXXX in pediatric clinical trials.

@entity1 @entity1331 @entity7553 @entity364 @entity1398 @entity1583 @entity3
BACKGROUND: Pediatric @entity1 with invasive @entity364 are often fragile hosts with multiple underlying conditions. Safety is an important feature of antifungal agents to be used in this setting. This study aims to evaluate safety of @entity1331 in pediatric @entity1 (<16 years of age), enrolled in different studies including pharmacokinetic evaluations and clinical trials for @entity3 , @entity7553 , and antifungal prophylaxis. METHODS: Adverse event (AE) data were pooled from 6 clinical trials conducted in Europe, the Americas, and Asia. RESULTS: A total of 296 @entity1 with a mean    standard deviation age of 6.5    5.1 years received >= 1 dose of @entity1331 ; 66 were <1 year of age; 38 were premature. Other common underlying conditions were hematopoietic stem cell transplantation (33.8%) and @entity1583 (29.1%). Approximately 40% of @entity1 were @entity1398 at baseline (absolute neutrophil count <500 cells/mm). Median daily @entity1331 dose was 1.7 mg/kg overall (range, 0.4-8.6 mg/kg) and 2.0 mg/kg (range, 0.8-7.7 mg/kg) for neonates <4 weeks old. Median treatment duration was 15 days (range, 1-425 days). During the study, AEs regardless of causality were recorded in 93.2% of subjects; 26.7% were classified as at least possibly related to study drug; and 34% of subjects had AEs meeting criteria for serious AE; of which, 4.7% of subjects experienced serious AEs at least possibly related to study drug. Study drug was discontinued because of AEs in 7 @entity1 (2.4%). No trends were observed with respect to analysis of AEs by dose or duration of treatment. CONCLUSIONS: @entity1331 was well tolerated by @entity1 of all ages including those with life-threatening underlying conditions. AEs thought to be drug related occasionally lead to discontinuation of the treatment.
