Number of reported adverse events and serious adverse events
| Sequential monotherapy | Step-up combination therapy | Initial combination with prednisone | Initial combination with infliximab | p Value | |
|---|---|---|---|---|---|
| N=40 | N=45 | N=56 | N=43 | ||
| 0–1 year follow-up | |||||
| AE, n* | 31 | 51 | 41 | 34 | 0.414 |
| SAE, n* | 3 | 3 | 6 | 1 | 0.400 |
| 0–10 year follow-up | |||||
| Total AE, n* | 293 | 292 | 368 | 312 | 0.872 |
| Patients with AE, n (%) | 36 | 39 | 55 | 41 | 0.113 |
| Total SAE, n* | 50 | 33 | 60 | 43 | 0.183 |
| Patients with SAE, n (%) | 25 (63) | 19 (42) | 27 (48) | 22 (51) | 0.300 |
| Patients with serious infection, n (%) | 9 (23) | 5 (11) | 5 (9) | 3 (7) | 0.124 |
| Patients with malignancy, n (%) | 3 (8) | 2 (4) | 8 (14) | 6 (14) | 0.310 |
| Deceased, n† | 1 | 4 | 1 | 4 | 0.220 |
*More events per patient possible.
†Causes of death, group 1: 1 ischaemic colon after complicated diverticulitis surgery; group 2: 1 lung carcinoma, 1 stomach cancer, 2 unknown; group 3: 1 lung carcinoma; group 4: 1 oesophagus carcinoma, 1 cardiac arrest, 1 lung carcinoma, 1 unknown.
AE, adverse event; SAE, serious adverse event.