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.