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Imbruvica · 4.8 Undesirable effects · 2
Eintrag öffnenImbruvica · 4.8 · 10 Neoplasms Common Non-melanoma skin cancer* 5 1 benign, malignant Basal cell carcinoma 3 <1 and unspecified
Eintrag öffnenImbruvica · 4.8 · 11 Respiratory, Very Cough* 24 <1 thoracic and common mediastinal disorders Gastrointestinal Very Diarrhoea 47
Eintrag öffnenImbruvica · 4.8 · 12 Neoplasms benign, Basal cell carcinoma 1 <1 malignant and unspecified (incl cysts and polyps) Blood and Ver
Eintrag öffnenImbruvica · 4.8 · 13 atrial fibrillation, acute kidney injury, diarrhoea, rash, and interstitial lung disease. Adverse reactions
Eintrag öffnenImbruvica · 4.8 · 53 Tabulated list of adverse reactions Adverse reactions in patients treated with ibrutinib for B-cell maligna
Eintrag öffnenImbruvica · 4.8 · 54 Uncommon Eye haemorrhage‡ <1 0 Uveitis* <1 0 Cardiac disorders Common Cardiac failure*, # 2 1 Atrial fibril
Eintrag öffnenImbruvica · 4.8 · 55 Table 3: Adverse reactions reported in the IMBRUVICA arm of the TRIANGLE Study†
Eintrag öffnenImbruvica · 4.8 · 56 † Frequencies are rounded to the nearest integer. * Terms required grouping. # Includes events with fatal o
Eintrag öffnenImbruvica · 4.8 · Description of selected adverse reactions Discontinuation and dose reduction due to adverse reactions Of the 1
Eintrag öffnenImbruvica · 4.8 · Description of selected adverse reactions Discontinuation and dose reduction due to adverse reactions Of the 1
Eintrag öffnenImbruvica · 4.8 · Elderly Of the 1 981 patients treated with IMBRUVICA, 50% were 65 years of age or older. Grade 3 or higher pne
Eintrag öffnenImbruvica · 4.8 · Elderly Of the 1 981 patients treated with IMBRUVICA, 50% were 65 years of age or older. Grade 3 or higher pne
Eintrag öffnenImbruvica · 4.8 · Long-term safety The safety data from long-term treatment with IMBRUVICA over 5 years from 1 284 patients (tre
Eintrag öffnenImbruvica · 4.8 · Long-term safety The safety data from long-term treatment with IMBRUVICA over 5 years from 1 284 patients (tre
Eintrag öffnenImbruvica · 4.8 · N=265 All Grade ≥3 System Organ Frequency Adverse Reactions Grades (%) Class (All Grades) (%) Infections and V
Eintrag öffnenImbruvica · 4.8 · N=265 All Grade ≥3 System Organ Frequency Adverse Reactions Grades (%) Class (All Grades) (%) Infections and V
Eintrag öffnenImbruvica · 4.8 · Paediatric population The safety assessment is based on data from a phase 3 study of IMBRUVICA in combination
Eintrag öffnenImbruvica · 4.8 · Paediatric population The safety assessment is based on data from a phase 3 study of IMBRUVICA in combination
Eintrag öffnenImbruvica · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
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