Table 4.
Safety Events
| Safety Event | Trial 1 |
Trial 2 |
Trial 4 |
All Trials |
|||||
|---|---|---|---|---|---|---|---|---|---|
| Fluconazole (n = 53) | Placebo (n = 50) | Fluconazole (n = 50) | Placebo (n = 50) | Fluconazole (n = 189) | Placebo (n = 173) | Fluconazole | Placebo | P Valuea | |
| Necrotizing enterocolitis | 4 (8) | 6 (12) | 2 (4) | 6 (12) | 25 (13) | 23 (13) | 31/292 (11) | 35/273 (13) | .42 |
| Spontaneous intestinal perforation | … | … | 2 (4) | 5 (10) | 16 (8) | 9 (5) | 18/239 (8) | 14/223 (6) | .60 |
| Chronic lung disease | 31 (58) | 25 (50) | … | … | 114 (60) | 93 (54) | 145/242 (60) | 118/223 (53) | .13 |
| Grade III/IV IVH or PVL | 7 (13) | 7 (14) | 8 (16) | 9 (18) | 37 (20) | 34 (20) | 52/292 (18) | 50/273 (18) | .88 |
| Retinopathy of prematurity | … | … | 15 (30) | 11 (22) | 29 (15) | 25 (14) | 44/239 (18) | 36/223 (16) | .52 |
| Abnormal ALT | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1) | 1/292 (<1) | 1/273 (<1) | .96 |
| Abnormal AST | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (2) | 1 (1) | 3/292 (1) | 1/272 (<1) | .38 |
| Abnormal alkaline phosphatase | … | … | 0 (0) | 1 (2) | 18 (10) | 20 (12) | 18/239 (8) | 21/223 (9) | .43 |
| Abnormal direct bilirubin | … | … | 0 (0) | 4 (8) | 32 (17) | 31 (18) | 32/239 (13) | 35/223 (16) | .44 |
Data are presented as No. (%) or no./No. (%). Safety data not available for trial 3.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; IVH, intraventricular hemorrhage; PVL, periventricular leukomalacia.
a All P values for fluconazole vs placebo.