Table 4 Adverse effects treated with ATG+CsA+AVA and CsA+AVA.
Adverse events, N (%) | All (N = 84) | ATG+CsA+AVA group (N = 42) | CsA+AVA group (N = 42) | P value |
|---|---|---|---|---|
No. of patients with AEs | 42 (50.0%) | 27 (64.3%) | 15 (35.7%) | 0.009 |
Grade ≥3 | 10 (11.9%) | 8 (19.0%) | 2 (4.8%) | 0.043 |
Grade <3 | 36 (42.9%) | 21 (50.0%) | 15 (35.7%) | 0.186 |
No. of patients with SAEs | 15 (17.9%) | 11 (26.2%) | 4 (9.5%) | 0.047 |
Infection | 14 (16.7%) | 11 (26.2%) | 3 (7.1%) | 0.019 |
Gastrointestinal disorders | 10 (11.9%) | 4 (9.5%) | 6 (14.3%) | 0.738 |
Fatigue | 9 (10.7%) | 5 (11.9%) | 4 (9.5%) | 1.000 |
Bilirubin increase | 8 (9.5%) | 7 (16.7%) | 1 (2.4%) | 0.057 |
Renal dysfunction | 8 (9.5%) | 6 (14.3%) | 2 (4.8%) | 0.265 |
Infusion reaction | 7 (8.3%) | 7 (16.7%) | 0 (0%) | 0.012 |
Headache | 7 (8.3%) | 3 (7.1%) | 4 (9.5%) | 1.000 |
Cardiac toxicity | 7 (8.3%) | 7 (16.7%) | 0 (0%) | 0.012 |
Elevated liver enzymes | 4 (4.8%) | 3 (7.1%) | 1 (2.4%) | 0.616 |
Serum sickness | 3 (3.6%) | 3 (7.1%) | 0 (0%) | 0.241 |
Gingival hyperplasia | 3 (3.6%) | 1 (2.4%) | 2 (4.8%) | 1.000 |
Edema | 3 (3.6%) | 1 (2.4%) | 2 (4.8%) | 1.000 |
Ulcer of the oral cavity | 3 (3.6%) | 2 (4.8%) | 1 (2.4%) | 1.000 |