An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a prospective, non-randomised study conducted between May 2011 to November 2015, 6 women were described, who developed various toxicities during treatment with bevacizumab, carboplatin or paclitaxel for epithelial ovarian cancer (EOC) [not all routes, dosages, time to reactions onset and outcomes stated].
Patient 1: The woman developed hypertension during treatment with carboplatin and paclitaxel. The woman had a diagnosis of EOC, for which she initially underwent maximal surgical debulking. Thereafter, she started receiving paclitaxel 175 mg/m2 and carboplatin (AUC 6) on day 1 every 3 weeks. During the chemotherapy, she developed grade 2 hypertension. Despite this, she completed the scheduled 6 cycles of the chemotherapy.
Patient 2: The woman developed hypertension during...
- Vatsa R, et al. Frontline use of Bevacizumab in ovarian cancer: Experience from India. National Medical Journal of India 31: 15-18, No. 1, Jan-Feb 2018. Available from: URL: http://doi.org/10.4103/0970-258X.243406 - India