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Besponsa · 4.8 · Description of selected adverse reactions
Eintrag öffnenBesponsa · 4.8 · For clinical management of TLS, see section 4.4.
Eintrag öffnenBesponsa · 4.8 · For clinical management of bleeding/haemorrhagic events, see section 4.4.
Eintrag öffnenBesponsa · 4.8 · For clinical management of hepatotoxicity, including VOD/SOS, see section 4.4.
Eintrag öffnenBesponsa · 4.8 · For clinical management of infections, see section 4.4.
Eintrag öffnenBesponsa · 4.8 · For clinical management of infusion-related reactions, see section 4.4.
Eintrag öffnenBesponsa · 4.8 · For periodic monitoring of ECG and electrolyte levels, see section 4.4.
Eintrag öffnenBesponsa · 4.8 · For periodic monitoring of increased amylase and lipase, see section 4.4.
Eintrag öffnenBesponsa · 4.8 · General disorders and Pyrexia (32%) administration site conditions Fatigue (35%) Chills (11%) Investigations I
Eintrag öffnenBesponsa · 4.8 · Hepatotoxicity, including VOD/SOS
Eintrag öffnenBesponsa · 4.8 · Immunogenicity
Eintrag öffnenBesponsa · 4.8 · In Cohort 3 of the Phase 2 ITCC-059 trial thirty-five VHR first relapsed BCP-ALL patients had at least 1 adver
Eintrag öffnenBesponsa · 4.8 · In adult patients who received BESPONSA, the most common (≥ 2%) serious adverse reactions were infection (23%)
Eintrag öffnenBesponsa · 4.8 · In clinical studies of inotuzumab ozogamicin in adult patients with relapsed or refractory ALL, 7/236 (3%) pat
Eintrag öffnenBesponsa · 4.8 · In clinical study ITCC-059 of inotuzumab ozogamicin in paediatric patients with relapsed or refractory ALL (N=
Eintrag öffnenBesponsa · 4.8 · In paediatric patients, liver test abnormalities occurred with Grade 3 or 4 increases in AST, ALT, and blood b
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%)
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