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Besponsa · 4.8 · In clinical study ITCC-059 of inotuzumab ozogamicin in paediatric patients with relapsed or refractory ALL (N=
Eintrag öffnenBesponsa · 4.8 · In the adult pivotal clinical study (N=164), VOD/SOS was reported in 23 (14%) patients including 5 (3%) patien
Eintrag öffnenBesponsa · 4.8 · In the adult pivotal clinical study (N=164), bleeding/haemorrhagic events, mostly mild in severity, were repor
Eintrag öffnenBesponsa · 4.8 · In the adult pivotal study (N=164), TLS, which may be life-threatening or fatal, was reported in 4/164 (2%) pa
Eintrag öffnenBesponsa · 4.8 · In the adult pivotal study (N=164), hyperbilirubinaemia and increased transaminases were reported in 35 (21%)
Eintrag öffnenBesponsa · 4.8 · In the adult pivotal study (N=164), increases in amylase and lipase were reported in 8 (5%) and 15 (9%) patien
Eintrag öffnenBesponsa · 4.8 · In the adult pivotal study (N=164), infections, including serious infections, some of which were life-threaten
Eintrag öffnenBesponsa · 4.8 · In the adult pivotal study (N=164), infusion-related reactions were reported in 17 (10%) patients. All events
Eintrag öffnenBesponsa · 4.8 · In the adult pivotal study (N=164), maximum increases in QTcF ≥ 30 msec and ≥ 60 msec from baseline were measu
Eintrag öffnenBesponsa · 4.8 · In the adult pivotal study (N=164), thrombocytopenia and neutropenia were reported in 83 (51%) and 81 (49%) pa
Eintrag öffnenBesponsa · 4.8 · In the paediatric study (N=53), 22 (42%) patients had haemorrhage. The frequencies of specific bleeding/haemor
Eintrag öffnenBesponsa · 4.8 · In the paediatric study (N=53), 23 (43%) patients had infections. The frequencies of the specific infections w
Eintrag öffnenBesponsa · 4.8 · In the paediatric study (N=53), 6 (11%) patients had Grade 3 TLS.
Eintrag öffnenBesponsa · 4.8 · In the paediatric study (N=53), Grade 3 anaemia and Grade 3 febrile neutropenia were reported in 20 (38%) and
Eintrag öffnenBesponsa · 4.8 · In the paediatric study (N=53), VOD occurred in 8 (15%) of patients treated with single agent BESPONSA. Among
Eintrag öffnenBesponsa · 4.8 · In the paediatric study (N=53), increases in QTcF of > 60 msec from baseline occurred in 7/49 (14%) patients,
Eintrag öffnenBesponsa · 4.8 · In the paediatric study (N=53), increases in amylases was reported in 1 (2%) patient as Grade 1.
Eintrag öffnenBesponsa · 4.8 · In the paediatric study (N=53), infusion-related reactions were reported in 23 (43%) patients. The most freque
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 (
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