Children Safety Information
What were the side effects seen in the trials with children with Ph+ CML in CP?
Adverse Reactions reported in ≥10% of SPRYCEL-treated pediatric patients with Ph+ CML in CP (n=97)
Ninety-seven children were included in total in the studies that looked at the safety profile of SPRYCEL. One of the children (1%) stopped taking treatment because of side effects.
According to Common Terminology Criteria for Adverse Events (CTCAE), Grade 3 side effects are considered severe, and Grade 4 side effects are considered potentially life-threatening.