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Rydapt · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenRydapt · 4.8 Undesirable effects · 1
Eintrag öffnenRydapt · 4.8 · 10 Eye disorders Eyelid oedema 3.1 0 Common Cardiac disorders Hypotension 14.4 5.5 Very common Sinus tachycard
Eintrag öffnenRydapt · 4.8 · 11 Investigations Haemoglobin decreased* 97.3 78.5 Very common ANC decreased* 86.7 85.8 Very common ALT increa
Eintrag öffnenRydapt · 4.8 · 12 Vascular disorders Hypotension 9.2 2.1 Common Haematoma 6.3 0.7 Common Respiratory, thoracic and mediastina
Eintrag öffnenRydapt · 4.8 · 9 duration of exposure to Rydapt was 11.4 months (range: 0 to 81 months).
Eintrag öffnenRydapt · 4.8 · AML Table 3 presents the frequency category of ARs reported in the phase III study in patients with newly diag
Eintrag öffnenRydapt · 4.8 · AML The safety evaluation of Rydapt (50 mg twice daily) in patients with newly diagnosed FLT3-mutated AML is b
Eintrag öffnenRydapt · 4.8 · ARs are listed according to MedDRA system organ class. Within each system organ class, the ARs are ranked by f
Eintrag öffnenRydapt · 4.8 · ARs reported during the maintenance phase led to discontinuation of 1.2% of patients in the Rydapt arm and non
Eintrag öffnenRydapt · 4.8 · ARs that led to treatment discontinuation occurred in 9.2% of patients. The most frequent (incidence ≥1%) were
Eintrag öffnenRydapt · 4.8 · ASM, SM-AHN and MCL Table 4 presents the frequency category of ARs based on pooled data from two studies in pa
Eintrag öffnenRydapt · 4.8 · ASM, SM-AHN and MCL The safety of Rydapt (100 mg twice daily) as a single agent in patients with ASM, SM-AHN a
Eintrag öffnenRydapt · 4.8 · Adverse reaction Rydapt (100 mg twice daily) Frequency category N=142 All grades Grades 3/4 % % Infections and
Eintrag öffnenRydapt · 4.8 · All grades Grades 3/4 Rydapt + Rydapt + Adverse reaction chemo chemo Frequency category n=2291 n=3451 % % Infe
Eintrag öffnenRydapt · 4.8 · Description of selected adverse reactions
Eintrag öffnenRydapt · 4.8 · Discontinuation due to any adverse reaction occurred in 3.1% of patients in the Rydapt arm versus 1.3% in the
Eintrag öffnenRydapt · 4.8 · Dose modifications (interruption or adjustment) due to ARs occurred in 31% of patients. The most frequent ARs
Eintrag öffnenRydapt · 4.8 · Gastrointestinal disorders Nausea, vomiting and diarrhoea were observed in AML, ASM, SM-AHN and MCL patients.
Eintrag öffnenRydapt · 4.8 · Most of the haematological abnormalities reported occurred during the induction and consolidation phase when t
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