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Table 4 Adverse events

From: Comparison of amphotericin B deoxycholate in combination with either flucytosine or fluconazole, and voriconazole plus flucytosine for the treatment of HIV-associated cryptococcal meningitis: a prospective multicenter study in China

Event

No. (%) of patients, by regimen

p-value

 

Group1, AmB-D + 5-FC

(N = 78)

Group 2, VCZ + 5FC

(N = 28)

Group 3, AmB-D + Flu

(N = 50)

 

Any clinical adverse event—no. of patients (%)

31 (39.7)

12 (42.9)

24 (48)

0.654

New neurologic sign or symptom—no. of patients (%)

19 (24.4)

11 (39.3)

14 (28)

0.322

Seizure—no. of patients (%)

3 (3.8)

2 (7.1)

5 (10)

0.413*

Rash—no. of patients (%)

7 (9)

1 (3.6)

5 (10)

0.687*

Hyperpyrexia—no. of patients (%)

5 (6.4)

1 (3.6)

4 (8)

0.830*

Respiratory system disorder

5 (6.4)

0 (0)

6 (12)

0.127*

Gastrointestinal disorder

2 (2.6)

1 (3.6)

2 (4)

0.852*

Any adverse laboratory event—no. of patients (%)

 Grade 3 or 4

49 (62.8)

7 (25)

34 (68)

 < 0.001

 Grade 3

38 (48.7)

5 (17.9)

27 (54)

0.005

 Grade 4

25 (32.1)

2 (7.1)

15 (30)

0.033

Anemia—no. of patients (%)

 Grade 3

19 (24.4)

2 (7.1)

9 (18)

0.135

 Grade 4

16 (20.5)

0 (0)

13 (26)

0.012

Hypokalemia—no. of patients (%)

 Grade 3

12 (15.4)

1 (3.6)

8 (16)

0.239*

 Grade 4

2 (2.6)

0 (0)

0 (0)

0.686*

Leukopenia—no. of patients (%)

 Grade 3

5 (6.4)

0 (0)

5 (10)

0.213*

 Grade 4

3 (3.8)

0 (0)

1 (2)

0.820*

Hyperuricemia—no. of patients (%)

 Grade 3

5 (6.4)

0 (0)

4 (8)

0.355*

 Grade 4

4 (5.1)

1 (3.6)

1 (2)

0.856*

Thrombocytopenia—no. of patients (%)

 Grade 3

5 (6.4)

2 (7.1)

4 (8)

0.918*

 Grade 4

2 (2.6)

1 (3.6)

2 (4)

0.852*

Increase Creatinine—no. of patients (%)

 Grade 3

2 (2.6)

0

4 (8)

0.263*

 Grade 4

0

0

0

–

Other grade 3 or 4 adverse event—no. of patients (%)‡

7 (9)

1 (3.6)

5 (10)

0.687*

  1. All clinical adverse events and all laboratory events of grades 3 or 4 were classified as severe adverse events
  2. *p-values correspond to overall comparisons among the three groups using Fisher’s exact test
  3. ‡Other adverse events occurred in less than 3% of patients, except for hyponatremia (which occurred in 3.2% of all patients)