Nebenwirkungen · Docetaxel Kabi
DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 208–209
HOS-215060 · Präparat HOS-155350
208 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.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-08-04T15:44:00Z · SHA-256 4ec115d98d201d84de2340a9fdabdd8a6db17b0a20954d72cafab8a7e3eaf6e6 · Passage 82df8868ca50f33ba0b47ea501f2a6f88296f70f18acf414c8851ca307229700 · Zeichen 37703–38330 im Abschnitt