3.1. Safety
nausea, vomiting, anemia, abdominal pain
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, ANEMIA
Most of the study patients received 8 or more doses of nimotuzumab and at least 2 cycles of chemotherapy. Adverse events were reported in 49 patients (73.11%). A total of 319 adverse events of 83 different types were recorded. Treatment-related adverse events were recorded in 8.1% of patients. Severe AEs related to the treatment were registered in 1.5% of the patients, of these only four AEs (1.2%) related to the monoclonal (5.9% of the patients had treatment-related adverse events, and the proportion of patients with at least one serious adverse event related to the treatment was 1.5%. Most of the related AEs were mild and moderate and progressed towards recovery or improvement. No patient died from any adverse event associated with the use of the monoclonal antibody. The most frequent AEs were nausea (10%), anemia (8%), abdominal pain (8%), weakness (5%), and vomiting (5%). The frequency of related AE was 8.1%, and the proportion of serious AE related (very probable, probable, or possible) with the use of nimotuzumab was 1.2%. 