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. 2016 Jan 6;94(1):93–98. doi: 10.4269/ajtmh.14-0657

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.