Table 3.
Summary of safety results at 48 weeksa
| Methotrexate monotherapy (n = 282) | Etanercept monotherapy (n = 282) | Combination therapy (n = 284) | |
|---|---|---|---|
| Any adverse event | 212 (75.2) | 191 (67.7) | 216 (76.1) |
| Serious adverse eventb | 16 (5.7) | 19 (6.7) | 17 (6.0) |
| Adverse events leading to discontinuation of investigational product | 19 (6.7) | 16 (5.7) | 20 (7.0) |
| Treatment‐related adverse events | 64 (22.7) | 71 (25.2) | 79 (27.8) |
| Fatal adverse events | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Adverse events occurring in ≥5%of patients | |||
| Nausea | 37 (13.1) | 18 (6.4) | 41 (14.4) |
| Nasopharyngitis | 22 (7.8) | 21 (7.4) | 27 (9.5) |
| Upper respiratory tract infection | 21 (7.4) | 18 (6.4) | 23 (8.1) |
| Diarrhea | 17 (6.0) | 13 (4.6) | 14 (4.9) |
| Headache | 15 (5.3) | 12 (4.3) | 17 (6.0) |
| Bronchitis | 9 (3.2) | 14 (5.0) | 19 (6.7) |
| Vomiting | 15 (5.3) | 7 (2.5) | 10 (3.5) |
a
Adverse events were categorized using the Medical Dictionary for Regulatory Activities, version 21. Values are the number (%) of patients.
b
The most common serious adverse events were of the system organ class infections and infestations, which occurred in 1.1% of patients in the methotrexate monotherapy arm, 2.8% of patients in the etanercept monotherapy arm, and 2.5% of patients in the combination therapy arm.