Safety data from the ICON7 trial1
ICON7 was a randomised(How subjects are assigned to a treatment arm in a study. The treatment a subject receives is determined by chance alone), open-label(A type of clinical trial in which both the researchers and participants know which treatment is being administered), two-arm, multicentre trial comparing standard chemotherapy (carboplatin and paclitaxel) with Avastin 7.5mg/kg every 3 weeks in combination with standard chemotherapy and continued as a single agent for a maximum of 12 months in patients with newly diagnosed epithelial ovarian cancer.2
ICON7: all-grade adverse events(Symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study) consistent with those previously reported with Avastin1,2
The safety profile of Avastin in combination with chemotherapy and continued as a single agent was consistent with the well-defined safety profile observed in clinical trials across a range of tumour(An abnormal growth of cells, forming a mass of tissue) types.1,2
ICON7: all-grade adverse events1
The most common all-grade adverse events of special interest with Avastin reported in ICON7 were bleeding and hypertension.1
ICON7: grade ≥3 adverse events consistent with those previously reported with Avastin1,2
The incidence of grade ≥3 events was generally low. The events most frequently reported were neutropenia, which is associated with chemotherapy and was similar in the two treatment arms, and grade ≥2 hypertension(High blood pressure), which is a known and manageable side effect of Avastin.1,2
ICON7: grade ≥3 adverse events1
The incidence of grade ≥3 adverse events in ICON7 was generally low, with the exception of neutropenia, which is associated with chemotherapy. Note that hypertension grades 2–4 is shown.1
References
- Perren TJ, Swart AM, Pfisterer J, et al. N Engl J Med 2011;365:2484–96
- Avastin Summary of Product Characteristics, 2012.