Table 2.
Grades of toxicity and comparison between arms
| Toxicities/Grades |
Placebo arm (%) n = 29 |
NAC arm (%) n = 28 |
P values | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 1 | 2 | 3 | 4 | 0 | 1 | 2 | 3 | 4 | ||
| Increased serum creatinine | 44.8 | 20.7 | 13.8 | 20.7 | 0.0 | 35.7 | 25.0 | 21.4 | 17.9 | 0.0 | 0.6517 (†) (a) |
| Decreased creatinine clearance* | 3.5 | 31.0 | 44.8 | 17.2 | 3.5 | 3.6 | 28.6 | 53.5 | 10.7 | 3.6 | 0.8620 (‡) (a) |
| Hyperuricemia | 72.4 | 27.6 | 0.0 | 0.0 | 0.0 | 75.0 | 14.3 | 0.0 | 0.0 | 10.7 | 0.8246 (†) (b) |
| Hyponatremia | 31.0 | 51.7 | — | 10.4 | 6.9 | 32.1 | 28.6 | — | 28.6 | 10.7 | 0.1128 (†) (a) |
| Hypomagnesemia | 13.8 | 75.9 | 10.3 | 0.0 | 0.0 | 10.7 | 67.9 | 14.3 | 7.1 | 0.0 | 1.0000 (‡) (b) |
| Hypokalemia | 96.6 | 3.4 | 0.0 | 0.0 | 0.0 | 89.3 | 10.7 | 0.0 | 0.0 | 0.0 | 0.3525 (‡) (b) |
| Hypophosphatemia | 75.9 | — | 24.1 | 0.0 | 0.0 | 89.3 | — | 10.7 | 0.0 | 0.0 | 0.2973 (‡) (b) |
| Hypocalcemia | 48.3 | 41.4 | 10.3 | 0.0 | 0.0 | 60.7 | 32.1 | 7.1 | 0.0 | 0.0 | 0.3459 (†) (b) |
| Hearing impaired | 24.0 | 32.0 | 28.0 | 16.0 | 0.0 | 20.8 | 16.7 | 25.0 | 37.5 | 0.0 | 0.3333 (†) (c) |
| Hypoalbuminemia | 62.1 | 17.2 | 20.7 | 0.0 | 0.0 | 64.3 | 17.8 | 14.3 | 3.6 | 0.0 | 0.8623 (†) (b) |
| Increased AST | 96.6 | 3.4 | 0.0 | 0.0 | 0.0 | 89.3 | 10.7 | 0.0 | 0.0 | 0.0 | 0.3525 (‡) (b) |
| Increased ALT | 69.0 | 31.0 | 0.0 | 0.0 | 0.0 | 75.0 | 21.4 | 3.6 | 0.0 | 0.0 | 0.6122 (†) (b) |
| Increased ALP | 89.7 | 10.3 | 0.0 | 0.0 | 0.0 | 89.3 | 10.7 | 0.0 | 0.0 | 0.0 | 1.0000 (‡) (b) |
| Increased total bilirubin | 93.2 | 3.4 | 0.0 | 0.0 | 0.0 | 96.4 | 3.6 | 0.0 | 0.0 | 0.0 | 1.0000 (‡) (b) |
| Anemia | 6.9 | 34.5 | 41.4 | 17.2 | 0.0 | 7.1 | 50.0 | 39.3 | 3.6 | 0.0 | 0.2832 (‡) (a) |
| Leukopenia | 24.1 | 17.3 | 44.8 | 13.8 | 0.0 | 28.6 | 21.4 | 25.0 | 21.4 | 3.6 | 0.4329 (†) (a) |
| Neutropenia | 44.8 | 20.7 | 27.6 | 6.9 | 0.0 | 42.8 | 14.3 | 10.7 | 28.6 | 3.6 | 0.0332 (†) (a) |
| Lymphopenia | 6.9 | 0.0 | 20.7 | 62.1 | 10.3 | 3.6 | 3.6 | 14.3 | 71.4 | 7.1 | 1.0000 (‡) (a) |
| Thrombocytopenia | 65.5 | 34.5 | 0.0 | 0.0 | 0.0 | 53.6 | 46.4 | 0.0 | 0.0 | 0.0 | 0.3581 (†) (b) |
| Nausea | 24.1 | 17.2 | 27.6 | 31.1 | — | 14.2 | 25.0 | 42.9 | 17.9 | — | 0.2155 (†) (a) |
| Vomiting | 41.4 | 24.1 | 13.8 | 20.7 | 0.0 | 50.0 | 14.2 | 17.9 | 17.9 | 0.0 | 0.8076 (†) (a) |
(†) Chi‐square test. (‡) Fisher's exact test. (a) Grade 0 vs grades 1 + 2 vs grades 3 + 4. (b) Grade 0 vs grades 1 + 2 + 3 + 4. (c) Grade 0 vs grade 1 vs grade 2 vs grade 3. — there is no grade for this toxicity. n: absolute number of patients. NAC: acetylcysteine, AST: aspartate aminotransferase. ALT: alanine aminotransferase. ALP: alkaline phosphatase. * Cockcroft–Gault formula.