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Tabrecta · 4.8 · 8 Dose interruptions were reported in 84 of 160 patients (52.5%). Adverse reactions requiring dose interruptio
Eintrag öffnenTabrecta · 4.8 · 9 Immune system disorders Hypersensitivity† Uncommon 0.3 0.3 Skin and subcutaneous tissue disorders Pruritus V
Eintrag öffnenTabrecta · 4.8 · Adverse reaction All grades All grades Grade 3/4 Frequency category % % Infections and infestations Cellulitis
Eintrag öffnenTabrecta · 4.8 · Adverse reactions from clinical studies (Table 3) are listed by MedDRA system organ class. Within each system
Eintrag öffnenTabrecta · 4.8 · Description of selected adverse reactions
Eintrag öffnenTabrecta · 4.8 · Dose reductions were reported in 53 of 160 patients (33.1%). Adverse reactions requiring dose reductions inclu
Eintrag öffnenTabrecta · 4.8 · Elderly Of the 160 patients with METex14 skipping mutations in the GEOMETRY mono-1 study who received 400 mg c
Eintrag öffnenTabrecta · 4.8 · Hepatic effects Any grade ALT/AST elevations were reported in 24 of 160 patients (15.0%). Grade 3 or 4 ALT/AST
Eintrag öffnenTabrecta · 4.8 · ILD/pneumonitis Any grade ILD/pneumonitis was reported in 12 of 160 patients (7.5%). Grade 3 ILD/pneumonitis w
Eintrag öffnenTabrecta · 4.8 · Peripheral oedema Any grade peripheral oedema was reported in 109 of 160 patients (68.1%). This adverse reacti
Eintrag öffnenTabrecta · 4.8 · Permanent discontinuation was reported in 22 of 160 patients (13.8%). The most frequent adverse reactions lead
Eintrag öffnenTabrecta · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenTabrecta · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenTabrecta · 4.8 · Serious adverse reactions were reported in 38 of 160 patients (23.8%) who received Tabrecta. Serious adverse r
Eintrag öffnenTabrecta · 4.8 · Special populations
Eintrag öffnenTabrecta · 4.8 · Summary of the safety profile
Eintrag öffnenTabrecta · 4.8 · Table 3 Adverse reactions in patients (N=160) harbouring METex14 skipping mutations in study GEOMETRY mono-1
Eintrag öffnenTabrecta · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenTabrecta · 4.8 · The most common adverse reactions are peripheral oedema (68.1%), nausea (45.0%), fatigue (35.6%), blood creati
Eintrag öffnenTabrecta · 4.8 · The safety of Tabrecta was evaluated in patients with locally-advanced or metastatic NSCLC in a pivotal, globa
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