Summary of worst Common Toxicity Criteria grades in clinical laboratory test results by trial treatment. Data from patients who switched from tocilizumab 4 mg/kg-MTX to tocilizumab 8 mg/kg-MTX are not included. MTX: methotrexate.
| Placebo-MTX, n = 392 | 4 mg/kg Tocilizumab-MTX, n = 146 | 8 mg/kg Tocilizumab-MTX, n = 532 | |
|---|---|---|---|
| White blood cell | |||
| N | 390 | 146 | 532 |
| Normal | 364 (93.3) | 111 (76.0) | 340 (63.9) |
| Grade 1 | 22 (5.6) | 20 (13.7) | 113 (21.2) |
| Grade 2 | 2 (< 1) | 12 (8.2) | 75 (14.1) |
| Grade 3 | — | 2 (1.4) | 4 (< 1) |
| Grade 4 | 2 (< 1) | 1 (< 1) | — |
| Platelets | |||
| N | 390 | 146 | 532 |
| Normal | 383 (98.2) | 133 (91.1) | 447 (84.0) |
| Grade 1 | 6 (1.5) | 10 (6.8) | 79 (14.8) |
| Grade 2 | — | 2 (1.4) | 4 (< 1) |
| Grade 3 | — | — | 1 (< 1) |
| Grade 4 | 1 (< 1) | 1 (< 1) | 1 (< 1) |
| Lymphocytes | |||
| N | 389 | 145 | 527 |
| Normal | 316 (81.2) | 109 (75.2) | 401 (76.1) |
| Grade 1 | 28 (7.2) | 8 (5.5) | 26 (4.9) |
| Grade 2 | 33 (8.5) | 24 (16.6) | 89 (16.9) |
| Grade 3 | 10 (2.6) | 3 (2.1) | 11 (2.1) |
| Grade 4 | 2 (< 1) | 1 (< 1) | — |
| Neutrophils | |||
| N | 388 | 145 | 527 |
| Normal | 368 (94.8) | 112 (77.2) | 287 (54.5) |
| Grade 1 | 12 (3.1) | 13 (9.0) | 124 (23.5) |
| Grade 2 | 5 (1.3) | 15 (10.3) | 91 (17.3) |
| Grade 3 | 1 (< 1) | 3 (2.1) | 22 (4.2) |
| Grade 4 | 2 (< 1) | 2 (1.4) | 3 (< 1) |
| Aspartate aminotransferase | |||
| N | 390 | 146 | 532 |
| Normal | 302 (77.4) | 75 (51.4) | 202 (38.0) |
| Grade 1 | 84 (21.5) | 58 (39.7) | 299 (56.2) |
| Grade 2 | 4 (1.0) | 10 (6.8) | 29 (5.5) |
| Grade 3 | — | 3 (2.1) | 2 (< 1) |
| Grade 4 | — | — | — |
| Alanine aminotransferase | |||
| N | 390 | 146 | 532 |
| Normal | 265 (67.9) | 57 (39.0) | 131 (24.6) |
| Grade 1 | 108 (27.7) | 66 (45.2) | 293 (55.1) |
| Grade 2 | 15 (3.8) | 14 (9.6) | 92 (17.3) |
| Grade 3 | 2 (< 1) | 9 (6.2) | 16 (3.0) |
| Grade 4 | — | — | — |
| Total bilirubin | |||
| N | 390 | 146 | 532 |
| Normal | 384 (98.5) | 130 (89.0) | 456 (85.7) |
| Grade 1 | 6 (1.5) | 12 (8.2) | 50 (9.4) |
| Grade 2 | — | 4 (2.7) | 25 (4.7) |
| Grade 3 | — | — | 1 (< 1) |
| Grade 4 | — | — | — |