Table 3. Adverse Events.*.
| Event | Group 1, Amphotericin B (N = 99) | Group 2, Amphotericin B and Flucytosine (N = 100) | Group 3, Amphotericin B and Fluconazole (N = 99) | P Value† |
|---|---|---|---|---|
| Any event | ||||
| At least one event — no. of patients (%) | 82 (83) | 85 (85) | 85 (86) | 0.85 |
| No. of events | 338 | 376 | 362 | |
| Hypokalemia — no. of patients (%) | ||||
| All grades | 54 (55) | 56 (56) | 54 (55) | 0.98 |
| Grades 3 and 4 | 20 (20) | 22 (22) | 13 (13) | 0.24 |
| Anemia — no. of patients (%) | ||||
| All grades | 62 (63) | 63 (63) | 57 (58) | 0.71 |
| Grades 3 and 4 | 46 (46) | 35 (35) | 29 (29) | 0.04 |
| Neutropenia — no. of patients (%) | ||||
| All grades | 19 (19) | 34 (34) | 32 (32) | 0.04 |
| Grades 3 and 4 | 2 (2) | 9 (9) | 9 (9) | 0.07 |
| Thrombocytopenia — no. of patients (%) | ||||
| All grades | 8 (8) | 15 (15) | 11 (11) | 0.32 |
| Grades 3 and 4 | 2 (2) | 4 (4) | 3 (3) | 0.91 |
| Rigor — no. of patients (%) | 13 (13) | 7 (7) | 6 (6) | 0.18 |
| Opportunistic infection — no. of patients (%) | 32 (32) | 32 (32) | 28 (28) | 0.79 |
| Rash — no. of patients (%) | 5 (5) | 7 (7) | 5 (5) | 0.86 |
| New neurologic sign or symptom — no. of patients (%) | 11 (11) | 12 (12) | 10 (10) | 0.97 |
| Seizure — no. of patients (%) | 2 (2) | 0 | 2 (2) | 0.4 |
| Elevated aminotransferase level — no. of patients (%) | ||||
| All grades | 38 (38) | 44 (44) | 42 (42) | 0.72 |
| Grades 3 and 4 | 11 (11) | 6 (6) | 14 (14) | 0.14 |
| Hyponatremia — no. of patients (%) | ||||
| All grades | 28 (28) | 33 (33) | 33 (33) | 0.71 |
| Grades 3 and 4 | 3 (3) | 8 (8) | 9 (9) | 0.19 |
| Hypercreatinemia — no. of patients (%) | ||||
| All grades | 34 (34) | 41 (41) | 46 (46) | 0.22 |
| Grades 3 and 4 | 2 (2) | 2 (2) | 2 (2) | 1.00 |
| Other — no. of patients (%)‡ | 28 (28) | 23 (23) | 31 (31) | 0.41 |
*
All opportunistic infections and all events of grade 3 or 4 were classified as severe adverse events. For details, see Table S3 in the Supplementary Appendix.
†
P values correspond to overall comparisons among the three groups with the use of Fisher’s exact test.
‡
Other adverse events occurred with a frequency of 0.3%, except nausea and vomiting (in 2.7% of all patients), sepsis (in 1.7%), and thrombophlebitis, hematemesis, diarrhea, and urinary retention (each in 0.7%).