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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective chart review, six children (three boys and three girls) aged 8−15 years were described, who developed rash and diarrhoea (one patient), rash and arthralgia (one patient), paronychia, fungal superinfections and skin lesions (one patient), paronychia (one patient), acneiform rash (one patient) and paronychia and diarrhoea (one patient) during treatment with trametinib for pilocytic astrocytoma (PA). Additionally, one of these six children developed cytopenia and neuropathy during treatment with carboplatin and vincristine for PA [not all durations of treatments to reactions onsets and outcomes stated].
Case 1: An 11-year-old girl, who was diagnosed with PA at the age of 1 years, started receiving treatment with oral trametinib tablet 0.5mg...