Safety Evaluation
Unique dose limiting toxicity (DLT) that are either only found or found
with increased incidence in pediatric patients was observed in several
drug (TABLE 3).
Irinotecan HCl (Camptosar) has reported different adverse event profile
in pediatric patients from adults in that dehydration associated with
severe hypokalemia and hyponatremia (Section 8.4 of USPI [20]).
Nilotinib (Tasigna) reported to have observed growth retardation
(Section 5.14 in USPI [11]). 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 (Section 8.4 of USPI [13]). Capecitabine (Xeloda) has
reported more frequently laboratory abnormalities. For details, refer to
section 8.4 of USPI [15].
TABLE 3. Unique DLTs observed in
oncology pediatric trials in response to written requests initiated
since 2001.