Description of Event in Safety of Fluconazole Prophylaxis in Infants

Description of Event Dataset
Study Description
This is a secondary analysis of clinical trials involving fluconazole prophylaxis in very low birthweight and extremely low birth weight infants. The objective of this study is to evaluate the safety of prophylactic fluconazole in premature infants. The prophylaxis trial observed gastrointestinal safety signals that have not been previously reported for fluconazole. Based on this observation additional information was obtained from the subjects enrolled in the prophylaxis trial. The fluconazole safety study analyzed the data to better evaluate these safety signals. Subjects who participated in the study titled, "Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants <750 Grams Birth Weight"