Variable | Continuation group (n=59) | Withdrawal group (n=51) | p Value |
Total number of AEs | 43 | 28 | 0.07 |
Number (%) of patients with at least one AE | 26 (44%) | 20 (39%) | 0.69 |
Number (%) of patients with ≥ grade 3 AE | 9 (15%) | 3 (6%) | 0.13 |
Type of AE | |||
Cancer | 7 | 4 | 0.54 |
Non-melanoma skin cancer | 2 | 2 | 0.99 |
Infection | 17 | 13 | 0.83 |
Cytopaenia | 7 | 1 | 0.066 |
Hepatitis | 2 | 2 | 0.99 |
Cardiovascular events | 5 | 0 | 0.060 |
AEs were classified according to the v3.0 Common Terminology Criteria for Adverse Events.