Table 5 Safety outcomes of fluconazole prophylaxis

Invasive fungal infection by fluconazole-resistant strains

1/7 (14.3)

6/12 (50.0)

0.17

Invasive fungal infection by natively fluconazole-resistant strains^a

2/7 (28.6)

2/12 (16.7)

0.60

Invasive fungal infection by fluconazole-resistant C. parapsilosis

0/7 (0)

5/12 (41.7)

0.11

Fungal colonization by fluconazole-resistant strains

4/25 (16.0)

9/55 (16.4)

>0.99

Fungal colonization by natively fluconazole-resistant strains^a

10/88 (11.4)

9/76 (11.8)

0.92

 Liver dysfunction (AST or ALT > 250 U/L)^b

8/156 (5.1)

11/262 (4.2)

0.66

 Renal dysfunction (creatinine > 1.5 mg/dL)^b

34/155 (21.9)

46/262 (17.6)

0.27

 Cholestasis (direct bilirubin > 2 mg/dL)^b

10/74 (13.5)

24/238 (10.1)

0.41

 Skin rash^b

10/150 (6.7)

16/262 (6.1)

0.84

 Rickets of prematurity^c

24/100 (24.0)

70/177 (39.4)

0.63

 Cerebral palsy

8/126 (6.4)

28/222 (12.6)

0.11

 Blindness, at least one eye

0/131 (0)

0/230 (0)

-

 Deafness, at least one ear

0/132 (0)

2/227 (0.9)

0.54

 Failure to catch up growth (<10 percentile)

52/108 (48.2)

87/192 (45.3)

0.64