Patients who discontinued study agent through Week 252. Values are n (%) unless otherwise specified.
| Characteristics | Placebo + MTX | Golimumab 100 mg + Placebo | Golimumab + MTX | Total | ||
|---|---|---|---|---|---|---|
| 50 mg | 100 mg | Combined | ||||
| Patients randomized, n | 133 | 133 | 89 | 89 | 178 | 444 |
| Patients treated, n | 133 | 133 | 89 | 89 | 178 | 444 |
| Patients who discontinued study agent | 43 (32.3) | 41 (30.8) | 17 (19.1) | 30 (33.7) | 47 (26.4) | 131 (29.5) |
| Reason for discontinuation | ||||||
| Initiated protocol-prohibited medication(s) | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinued oral study agent | 0 | 1 (0.8) | 0 | 0 | 0 | 1 (0.2) |
| Adverse event | 23 (17.3) | 18 (13.5) | 9 (10.1) | 14 (15.7) | 23 (12.9) | 64 (14.4) |
| Worsening of RA | 4 (3.0) | 1 (0.8) | 1 (1.1) | 0 | 1 (0.6) | 6 (1.4) |
| Unsatisfactory therapeutic effect | 4 (3.0) | 11 (8.3) | 4 (4.5) | 6 (6.7) | 10 (5.6) | 25 (5.6) |
| Lost to followup | 3 (2.3) | 1 (0.8) | 1 (1.1) | 1 (1.1) | 2 (1.1) | 6 (1.4) |
| Death | 0 | 3 (2.3) | 0 | 0 | 0 | 3 (0.7) |
| Other | 13 (9.8) | 7 (5.3) | 3 (3.4) | 9 (10.1) | 12 (6.7) | 32 (7.2) |
MTX: methotrexate; RA: rheumatoid arthritis.