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Besponsa · 4.8 · MedDRA System organ class Very common Common Infections and infestations Infectiona** (38%) Blood and lymphati
Eintrag öffnenBesponsa · 4.8 · Myelosuppression/cytopenias
Eintrag öffnenBesponsa · 4.8 · Regarding other risk factors, VOD/SOS was reported in 6/11 (55%) patients who received a HSCT conditioning reg
Eintrag öffnenBesponsa · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenBesponsa · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenBesponsa · 4.8 · Summary of safety profile in paediatric patients
Eintrag öffnenBesponsa · 4.8 · Summary of the safety profile in adult patients
Eintrag öffnenBesponsa · 4.8 · Table 5 shows the adverse reactions reported in adult patients with relapsed or refractory ALL who received BE
Eintrag öffnenBesponsa · 4.8 · Table 5. Adverse reactions reported in adult patients with relapsed or refractory B-cell precursor ALL who rec
Eintrag öffnenBesponsa · 4.8 · Table 6 shows the adverse reactions reported in paediatric patients with relapsed or refractory ALL who receiv
Eintrag öffnenBesponsa · 4.8 · Table 6. Adverse reactions reported in paediatric patients with relapsed or refractory B-cell precursor ALL wh
Eintrag öffnenBesponsa · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenBesponsa · 4.8 · The adverse reactions are presented by SOC and frequency categories, defined using the following convention: v
Eintrag öffnenBesponsa · 4.8 · The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the fo
Eintrag öffnenBesponsa · 4.8 · The most common (> 30%) adverse reactions in the paediatric study (N=53) were thrombocytopenia (51%), pyrexia
Eintrag öffnenBesponsa · 4.8 · The most common (≥ 2%) serious adverse reactions in the paediatric study were febrile neutropenia (15%), VOD (
Eintrag öffnenBesponsa · 4.8 · The most common (≥ 20%) adverse reactions in adult patients were thrombocytopenia (51%), neutropenia (49%), in
Eintrag öffnenBesponsa · 4.8 · Tumour lysis syndrome (TLS)
Eintrag öffnenBesponsa · 4.8 · VOD/SOS was reported up to 56 days after the final dose of inotuzumab ozogamicin without an intervening HSCT.
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