Safety Evaluation
Unique dose limiting toxicity (DLT) that are only found in pediatric patients was observed in several drug (TABLE 4).
Irinotecan HCl (Camptosar) has reported different adverse event profile in pediatric patients from adults in that dehydration associated with severe hypokalemia and hyponatremia. Nilotinib (Tasigna) reported to have observed growth retardation. Sunitinib malate (Sutent) has reported dose-limiting cardiotoxicity, which prompted amendment of the study to exclude patients with previous exposure to anthracyclines or cardiac radiation.
TABLE 3. Unique DLTs observed in oncology pediatric trials in response to written requests initiated since 2001.