Safety data: number of patients with AEs
| Duration of RA | Tofacitinib 5 mg two times a day | Tofacitinib 10 mg two times a day | MTX | |||
|---|---|---|---|---|---|---|
| Early (n=201) | Established (n=172) | Early (n=207) | Established (n=190) | Early (n=107) | Established (n=79) | |
| TEAEs, n (%) | 165 (82.1) | 132 (76.7) | 175 (84.5) | 159 (83.7) | 83 (77.6) | 64 (81.0) |
| Discontinuations due to AEs, n (%) | 22 (10.9) | 18 (10.5) | 21 (10.1) | 20 (10.5) | 14 (13.1) | 11 (13.9) |
| Serious infections, n (%) | 3 (1.5) | 8 (4.7) | 4 (1.9) | 4 (2.1) | 3 (2.8) | 2 (2.5) |
| SAEs, n (%)* | 17 (8.5) | 22 (12.8) | 15 (7.2) | 26 (13.7) | 11 (10.3) | 11 (13.9) |
| Deaths, n (%)* | ||||||
| Within 30-day rule | 0 (0.0) | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Outside 30-day rule | 2 (1.0) | 1 (0.6) | 1 (0.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Early RA was defined as disease duration <1 year, and established RA was defined as disease duration ≥1 year.
*Two patients had SAEs and one patient died before being randomised to treatment. Therefore, these events are not included in the above table.
AE, adverse event; MTX, methotrexate; n, number of patients; RA, rheumatoid arthritis; SAE, serious adverse event; TEAE, treatment-emergent adverse event.