Nebenwirkungen · Docetaxel Kabi
DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 163
HOS-214941 · Präparat HOS-155350
Acute leukaemia / Myelodysplastic syndrome After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%). One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years). Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%). After 10 years of follow-up in GEICAM 9805 STUDY, acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
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