Adverse events in patient population.
| Adverse Events | n (%) |
|---|---|
| Overall adverse events | 65 (54.5) |
| Estimated cumulative incidence after 6 mos/12 mos* | 40.0%/51.2% |
| Severe AE | 14 (11.8) |
| Discontinued MTX because of AE | 10 (8.4) |
| Discontinued MTX because of AE while receiving | |
| MTX monotherapy | 7 (5.9) |
| Estimated cumulative incidence after 6 mos/12 mos* | 3.1%/5.8% |
| Gastrointestinal AE | 39 (32.8) |
| Estimated cumulative incidence after 6 mos/12 mos* | 21.5%/31.9% |
| Hepatotoxicity | 28 (23.5) |
| Moderate hepatotoxicity | 25 (21.0) |
| Estimated cumulative incidence after 6 mos/12 mos* | 13.5%/16.3% |
| Infections | 36 (30.3) |
| Severe infections | 13 (10.2) |
| Dermatological AE | 11 (9.2) |
| Hematological AE | 1 (0.8) |
| Renal AE | 0 (0) |
| Central nervous system AE | 1 (0.8) |
↵* Estimated proportion of patients who experienced the event in the first 6 months/12 months of therapy. Estimates were obtained using Kaplan-Meier method. AE: adverse events; MTX: methotrexate.