Nebenwirkungen · Avastin
Avastin 25 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 19
HOS-113616 · Präparat HOS-093945
Congestive heart failure (CHF) In clinical trials with Avastin, congestive heart failure (CHF) was observed in all cancer indications studied to date, but occurred predominantly in patients with metastatic breast cancer. In four phase III trials (AVF2119g, E2100, BO17708 and AVF3694g) in patients with metastatic breast cancer CHF Grade 3 (NCI-CTCAE v.3) or higher was reported in up to 3.5% of patients treated with Avastin in combination with chemotherapy compared with up to 0.9% in the control arms. For patients in study AVF3694g who received anthracyclines concomitantly with bevacizumab, the incidences of Grade 3 or higher CHF for the respective bevacizumab and control arms were similar to those in the other studies in metastatic breast cancer: 2.9% in the anthracycline + bevacizumab arm and 0% in the anthracycline + placebo arm. In addition, in study AVF3694g the incidences of all Grade CHF were similar between the anthracycline + Avastin (6.2%) and the anthracycline + placebo arms (6.0%).
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 2026-01-27T12:02:00Z · SHA-256 66d06bf8e8d4853783377bc4046bd6b4b0e313cc348c230743646f93a9381bb1 · Passage e5b63ed682f0e0c9c2c727a8d0b85ff0b8fbd3fa17576372cde5937094057427 · Zeichen 34282–35288 im Abschnitt