Table 3.
Adverse events in Phase III/IV trials
| Trial | Treatment group | Any AEs | Serious AEs | Death | Serious infection | Neoplasm | Drug-related infusion reaction |
|---|---|---|---|---|---|---|---|
| SAMURAI26 | TCZ 8 mg/kg | 89% | 18% | 0 | 5% | 2% | 7% |
| MTX | 82% | 13% | 0 | 4% | 0 | ||
| SATORI25 | TCZ 8 mg/kg | 92% | 7% | 0 | 2% | 11.5% | |
| Placebo | 72% | 5% | 0 | 2% | |||
| OPTION29 | TCZ 4 mg/kg | 71% | 6% | 0 | 1% | 0 | |
| TCZ 8 mg/kg | 69% | 6% | 0 | 3% | 0 | ||
| Placebo | 63% | 6% | 0 | 1% | 2% | ||
| RADIATE32 | TCZ 4 mg/kg | 87% | 2% | 0 | 2% | 9.8% | |
| TCZ 8 mg/kg | 84% | 5% | 0 | 5% | 9.1% | ||
| Placebo | 81% | 3% | 0 | 3% | 6.3% | ||
| TOWARD30 | TCZ 8 mg/kg | 73% | 8% | 0.30% | 3% | ||
| Placebo | 61% | 4% | 0.50% | 2% | |||
| AMBITION35 | TCZ 8 mg/kg | 80% | 4% | 1% | 1% | 5.6% | |
| Placebo | 78% | 3% | 0.40% | 1% | 1.8% | ||
| ROSE31 | TCZ 8 mg/kg | 71% | 8.6% | 1% | 3% | 1% | |
| Placebo | 60% | 6.3% | 0 | 0 | 2% | ||
| ACT-RAY33 | TCZ 8 mg/kg + MTX | 70% | 6.1% | 1% | 2.2% | ||
| TCZ 8 mg/kg + placebo | 73% | 5.8% | 1% | 2.2% | |||
| ADACTA36 | TCZ 8 mg/kg | 82% | 12% | 1% | 4% | 1% | |
| Adalimumab | 83% | 10% | 0 | 4% | 1% |
Abbreviations: AE, adverse event; MTX, methotrexate; TCZ, tocilizumab.