Summary of adverse events (AE) by treatment course.
| Course 1, n = 2578, No. (%) | Course 2, n = 1890, No. (%) | Course 3, n = 1043, No. (%) | Course 4, n = 425, No. (%) | Course 5, n = 133, No. (%) | |
|---|---|---|---|---|---|
| Total Patient-years | 2456.25 | 1573.60 | 640.83 | 237.52 | 73.25 |
| Patients with an AE | 2145 (83) | 1391 (74) | 675 (65) | 248 (58) | 81 (61) |
| Total no. of AE | 9606 | 5184 | 2111 | 768 | 226 |
| AE/100 pt-yrs | 391.08 | 329.44 | 329.42 | 323.33 | 308.52 |
| 95% CI | 383.34, 398.98 | 320.59, 338.53 | 315.66, 343.77 | 301.26, 347.03 | 270.80, 351.48 |
| Patients with an SAE | 320 (12) | 197 (10) | 79 (8) | 21 (5) | 11 (8) |
| No. of SAE | 457 | 282 | 114 | 23 | 12 |
| SAE/100 pt-yrs | 18.61 | 17.92 | 17.79 | 9.68 | 16.38 |
| 95% CI | 16.98, 20.39 | 15.95, 20.14 | 14.81, 21.37 | 6.43, 14.57 | 9.30, 28.85 |
| Patients with an infection | 1210 (47) | 820 (43) | 379 (36) | 146 (34) | 43 (32) |
| No. of infections | 2416 | 1498 | 648 | 236 | 65 |
| Infections/100 pt-yrs | 98.36 | 95.20 | 101.12 | 99.36 | 88.73 |
| 95% CI | 94.52, 102.36 | 90.50, 100.14 | 93.63, 109.21 | 87.46, 112.88 | 69.58, 113.15 |
| Patients with a serious infection | 86 (3) | 53 (3) | 26 (2) | 8 (2) | 4 (3) |
| No. of serious infections | 110 | 60 | 31 | 9 | 5 |
| Serious infections/100 pt-yrs | 4.48 | 3.81 | 4.84 | 3.79 | 6.83 |
| 95% CI | 3.72, 5.40 | 2.96, 4.91 | 3.40, 6.88 | 1.97, 7.28 | 2.84, 16.40 |
| Patients who withdrew due to AE | 78 (3.2) | 36 (1.8) | 6 (< 1) | 2 (< 1) | 0 |
SAE: serious adverse event.