Table 1.
Summary of the 90 studies that reported on the safety of fluconazole in paediatric populations included in this review
| Characteristics of studies | Number of studies | Number of patients |
|---|---|---|
| Type of study | n = 90 | n = 4,209 |
| Case series | 23 | 795 |
| Case reports | 38 | 65 |
| RCT | 14 | 1,793 |
| Cohort studies | 7 | 1,564 |
| Pharmacokinetics studies | 8 | 77 |
| Route of Administration | n = 90 | n = 4,209 |
| Oral | 27 | 1,465 |
| Intravenous and oral | 26 | 1,602 |
| Intravenous | 21 | 971 |
| Not reported | 13 | 170 |
| Intraperitoneal/rectal | 3 | 15 |
| Age groups | n = 90 | n = 4,209 |
| Preterm neonates | 20 | 2,354 |
| Term neonates | 7 | 43 |
| Term and preterm neonates | 4 | 37 |
| Other paediatric age groupsa | 59 | 1,775 |
RCT, Randomised controlled trial
aIncluding studies involving infants up to adolescence (some of which included some neonates) and paediatric studies for which the age group was not stated