At the time of cut off, treatment related adverse events of any severity grade were reported in 83% of sunitinib-treated and 59% of placebo treated patients, and serious treatment related adverse events were reported in 40% and 5% patients in each group, respectively.
Adverse events were generally mild to moderate and easily managed by dose reduction, dose interruption or standard supportive medical treatments. 19% patients in the sunitinib group and 8% in the placebo group discontinued treatment because of adverse events.
Other serious non haematological adverse events noted with sunitinib were hand-and-foot syndrome, diarrhoea, and hypertension. 8 (4%) of patients treated with sunitinib developed hypothyroidism, including one grade 4 case, and one patient in the placebo group developed a grade 1 case. Patients who were intolerant to imatinib on study were tolerant to sunitinib without recurrence of the toxic effects they had previously experienced on imatinib.r
Adverse Side Effects:r
© Lancet 2006