Nebenwirkungen · Zaltrap
ZALTRAP 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 13
HOS-215784 · Präparat HOS-155534
Venous thromboembolic events VTE include deep venous thrombosis and pulmonary embolism. In the pivotal study of MCRC patients, all grades VTE occurred in 9.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 7.3 % of patients treated with the placebo/FOLFIRI regimen. Grade 3-4 VTE occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen and in 6.3 % of patients treated with the placebo/FOLFIRI regimen. Pulmonary embolism occurred in 4.6 % of patients treated with the ZALTRAP/FOLFIRI regimen and 3.5 % of patients treated with the placebo/FOLFIRI regimen. Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of VTE (all grades) was 7.1 % for patients treated with ZALTRAP and 7.1 % for patients treated with placebo.
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Version 2024-08-29T14:23:00Z · SHA-256 5b4c1b4848635140cdb6155c414b72c6acf77bc314124cac5763c972a8858b1a · Passage 67f86269530aa1473fcb52bacd282cef6a7e6cc054b64a060f6be45f43c2e0df · Zeichen 14139–14962 im Abschnitt