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Columvi · 4.8 · Hospitalisations due to patients experiencing CRS following Columvi administration occurred in 22.1% of patien
Eintrag öffnenColumvi · 4.8 · Immune effector cell-associated neurotoxicity syndrome ICANS, including Grade 3 and higher, was reported in cl
Eintrag öffnenColumvi · 4.8 · In 145 patients, 7 patients (4.8%) experienced elevated liver function tests (AST and ALT > 3 ULN and/or tot
Eintrag öffnenColumvi · 4.8 · In patients with CRS, the most common manifestations of CRS included pyrexia (98.7%), hypotension (22.4%), chi
Eintrag öffnenColumvi · 4.8 · In patients with CRS, the most common manifestations of CRS included pyrexia (99.0%), tachycardia (25.5%), hyp
Eintrag öffnenColumvi · 4.8 · Neutropenia Neutropenia (including neutrophil count decreased) was reported in 40.0% of patients and severe ne
Eintrag öffnenColumvi · 4.8 · Of the 172 patients, 2 patients (1.2%) experienced elevated liver function tests (AST and ALT > 3 ULN) repor
Eintrag öffnenColumvi · 4.8 · Opportunistic infections CMV events were reported in 6/467 patients (1.3%) who received Columvi monotherapy, w
Eintrag öffnenColumvi · 4.8 · Out of the 76 patients with any grade CRS, 28 patients (36.8%) were treated with tocilizumab, 39 patients (51.
Eintrag öffnenColumvi · 4.8 · Permanent discontinuation of Columvi due to an adverse reaction occurred in 20.9% of patients. The most common
Eintrag öffnenColumvi · 4.8 · Permanent discontinuation of Columvi due to an adverse reaction occurred in 5.5% of patients. The most common
Eintrag öffnenColumvi · 4.8 · Pneumonitis Pneumonitis events (excluding pneumonia of infectious aetiology) were reported in 2 patients (1.2%
Eintrag öffnenColumvi · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenColumvi · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenColumvi · 4.8 · Serious infections Serious infections were reported in 15.9% of patients who received Columvi monotherapy. The
Eintrag öffnenColumvi · 4.8 · Serious infections were reported in 22.7% of patients who received Columvi with gemcitabine and oxaliplatin. T
Eintrag öffnenColumvi · 4.8 · Summary of the safety profile
Eintrag öffnenColumvi · 4.8 · System organ class Adverse reaction All grades Grade 34
Eintrag öffnenColumvi · 4.8 · System organ class Adverse reaction All grades Grade 34
Eintrag öffnenColumvi · 4.8 · Table 6. Adverse reactions reported in patients with relapsed or refractory DLBCL treated with Columvi monothe
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