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Elzonris
Eintrag öffnenElzonris · 4.1 Therapeutic indications · 1
Eintrag öffnenElzonris · 4.3 Contraindications · 1
Eintrag öffnenElzonris · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenElzonris · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenElzonris · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenElzonris · 4.5 · No interaction studies have been performed.
Eintrag öffnenElzonris · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenElzonris · 4.8 Undesirable effects · 1
Eintrag öffnenElzonris · 4.8 · 10 MedDRA System Frequency of CTCAE grade 3 and Frequency of all CTCAE grades Organ Class above Injury, poison
Eintrag öffnenElzonris · 4.8 · 11 • 94% (176/187) of patients evaluable for the presence of pre-existing ADA at baseline before treatment wer
Eintrag öffnenElzonris · 4.8 · 7 Table 3: Tabulated list of adverse reactions by MedDRA System Organ Class MedDRA System Frequency of CTCAE g
Eintrag öffnenElzonris · 4.8 · 8 MedDRA System Frequency of CTCAE grade 3 and Frequency of all CTCAE grades Organ Class above Vision blurred
Eintrag öffnenElzonris · 4.8 · 9 MedDRA System Frequency of CTCAE grade 3 and Frequency of all CTCAE grades Organ Class above Swelling face P
Eintrag öffnenElzonris · 4.8 · Adverse reactions grade 3 and above according to the Common Terminology Criteria for Adverse events (CTCAE) an
Eintrag öffnenElzonris · 4.8 · Adverse reactions occurring in ≥ 20% of patients treated with ELZONRIS were hypoalbuminemia, increased transam
Eintrag öffnenElzonris · 4.8 · Capillary leak syndrome Capillary leak syndrome was reported in 18% (32/176), with 12% (21/176) Grade 2, 3% (6
Eintrag öffnenElzonris · 4.8 · Description of selected adverse reactions
Eintrag öffnenElzonris · 4.8 · Haematological abnormalities Thrombocytopenia was reported in 30% (53/176) of patients treated with ELZONRIS m
Eintrag öffnenElzonris · 4.8 · Hepatotoxicity ALT and AST elevations were reported as adverse reactions in 47% (83/176) and 46% (81/176) of p
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