Table 4

Adverse events (AEs)

VariableContinuation group
(n=59)
Withdrawal group
(n=51)
p Value
Total number of AEs43280.07
Number (%) of patients with at least one AE26 (44%)20 (39%)0.69
Number (%) of patients with ≥ grade 3 AE9 (15%)3 (6%)0.13
Type of AE
Cancer740.54
Non-melanoma skin cancer220.99
Infection17130.83
Cytopaenia710.066
Hepatitis220.99
Cardiovascular events500.060
  • AEs were classified according to the v3.0 Common Terminology Criteria for Adverse Events.