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Simulect 10 mg powder and solvent for solution for injection or infusion Simulect 10 mg powder for solution for injection or infusion · Abschnitt 4.8 · PDF-Seite 16
HOS-089035 · Präparat HOS-083755
Incidence of malignant neoplasms: The overall incidence of malignancies among all patients in the individual studies was similar between the basiliximab and the comparator treatment groups. Overall, lymphoma/lymphoproliferative disease occurred in 0.1% (1/701) of patients in the basiliximab group compared with 0.3% (2/595) of patients receiving placebo, both in combination with dual and triple immunosuppressive therapy. Other malignancies were reported among 1.0% (7/701) of patients in the basiliximab group compared with 1.2% (7/595) of placebo patients. In a pooled analysis of two five- year extension studies, the incidence of LPDs and cancer was found to be equal with basiliximab 7% (21/295) and placebo 7% (21/291) (see section 4.4).
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Version 2025-12-19T11:51:00Z · SHA-256 733fba3a740348b21107babe9d9387936dfd68357cde53822fb186eb4a9d7e0d · Passage 9e6eeb6322e2313cacd5be645647340edc98f28b52752fad03e53ee2c5916943 · Zeichen 1906–2651 im Abschnitt