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* |