Table 5 Rates of serious adverse events during the blinded and open label extension period of the ARMADA trial.
| Serious adverse event | Events/100 patient‐years | |
|---|---|---|
| ARMADA blinded period* | ARMADA total exposure† | |
| Serious infections | 2.30 | 2.03 |
| Pneumonia | 2.30 | 0.56 |
| Urinary tract infections | 0.00 | 0.23 |
| Septic arthritis | 0.00 | 0.11 |
| Tuberculosis | 0.00 | 0.00 |
| Histoplasmosis | 0.00 | 0.00 |
| Demyelinating diseases | 0.00 | 0.11 |
| Lymphoma | 0.00 | 0.00 |
| SLE/lupus‐like syndrome | 0.00 | 0.00 |
| Congestive heart failure | 0.00 | 0.11 |
| Pancytopenia | 0.00 | 0.00 |
*87 patient‐years of total exposure; †886 patient‐years of total exposure (as of 31 August 2004).