Overview of adverse events (AE) pooled by treatment received up to Week 104 (safety population). Multiple occurrences of the same AE in one patient were counted once.
| Placebo-MTX, n = 392 | 4 mg/kg Tocilizumab-MTX, n = 597* | 8 mg/kg Tocilizumab-MTX, n = 983† | |
|---|---|---|---|
| Median duration on study, yrs | 0.54 | 0.92 | 1.08 |
| Total patient-yrs of treatment | 284.81 | 521.90 | 1320.41 |
| All AE, n (per 100 PY exposure to trial treatment) | 716 (251.4) | 1439 (275.7) | 3481 (263.6) |
| All serious AE, n (per 100 PY exposure to trial treatment) | 31 (10.9) | 63 (12.1) | 150 (11.4) |
| AE that led to withdrawal, n (per 100 PY exposure to trial treatment) | 12 (4.2) | 44 (8.4) | 97 (7.3) |
| AE that led to dose interruption, n (per 100 PY exposure to trial treatment) | 58 (20.4) | 160 (30.7) | 429 (32.5) |
| Deaths, n†† (per 100 PY exposure to trial treatment) | 1 (0.35) | 1 (0.19) | 8 (0.61) |
↵* Includes 146 non-switch patients and 451 switch patients.
↵† Includes 532 non-switch patients and 451 switch patients.
↵†† Causes of death were Wegener’s granulomatosis (placebo); pulmonary embolism (4 mg/kg tocilizumab-MTX); and gastroesophageal cancer, metastatic malignant melanoma, metastatic lung adenocarcinoma, cardiomyopathy, cerebral hemorrhage, gastrointestinal infection, bronchopneumonia, and sepsis (8 mg/kg tocilizumab-MTX). MTX: methotrexate.