Nebenwirkungen · Braftovi
Braftovi 50 mg hard capsules Braftovi 75 mg hard capsules · Abschnitt 4.8 · PDF-Seite 18
HOS-140094 · Präparat HOS-098444
Haemorrhage Melanoma and NSCLC Haemorrhagic events were observed in 16.7% (62/372) of patients in the Combo 450 ISP. Most events were Grade 1 or 2: 13.2% (49/372), and 3.5% (13/372) were Grade ≥3. Few patients required dose interruptions or dose reductions (2.4% or 9/372). Haemorrhagic events led to discontinuation of treatment in 0.8% (3/372) of patients. The most frequent haemorrhagic events were haematuria in 2.7% (10/372) of patients, haematochezia in 2.7% (10/372) and rectal haemorrhage in 2.2% (8/372) of patients. Fatal gastric ulcer haemorrhage, with multiple organ failure as a concurrent cause of death, occurred in one patient. Cerebral haemorrhage/intracranial haemorrhage was reported in 1.6% (6/372) of patients, with fatal outcome in 4 patients.
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