Table 3.
Summary of AEs in the study population
| AEs | Overall (N = 120) | Group A (N = 60) | Group B (N = 60) | P value |
|---|---|---|---|---|
| Allergy grade 2 (%) | 45 (37.5) | 20 (33.33) | 25 (41.67) | 0.34 |
| Fever grade 2 (%) | 24 (20) | 10 (16.66) | 14 (23.33) | 0.36 |
| Rigors/chills grade 2 (%) | 8 (6.66) | 2 (3.33) | 6 (1.00) | 0.27 |
| Vomiting, all grades | 6 (5.00) | 1 (1.66) | 5 (8.33) | 0.21 |
| Diarrhea, all grades | 4 (3.33) | 1 (1.66) | 3 (5.00) | 0.62 |
| Aspartate aminotransferase elevation, grade 1 | 8 (6.66) | 3 (5.00) | 5 (8.33) | 0.72 |
| Alanine aminotransferase elevation, all grades | 11 (9.16) | 3 (5.00) | 8 (13.33) | 0.20 |
| Alanine aminotransferase elevation, grade 1 | 6 (5.00) | 2 (3.33) | 4 (6.66) | 0.68 |
| Alanine aminotransferase elevation, grade 2 | 5 (4.16) | 1 (1.66) | 4 (6.66) | 0.36 |
| AE leading to treatment discontinuation | 0 | 0 | 0 | – |
AE = adverse events.
Gradation of AEs is according to National Cancer Institute Common Terminology Criteria Adverse Events, version 3. Group A: Fungisome™ 5 mg/kg body weight given for two consecutive days and Group B: Fungisome™ 7.5 mg/kg body weight given for two consecutive days.