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The three most severe side effects (Grades 3 and 4 by World Health Organization criteria) were leukopenia, thrombocytopenia, and mucositis.
Table 3 > -wrap-foot> shows the univariate relationships between the UGT1A1 genotypes and severe adverse effects (grades III and IV).
The most significant matuzumab-related side effects (grades 1 4) across all DLs were lethargy and rash affecting 11 and 13 patients, respectively.
In the phase III ICON4/AGO-OVAR-2.2 study, neurological and haematological toxic effects, grades 2 4 nausea and vomiting, and alopecia were experienced by 20 86% of patients receiving paclitaxel plus a platinum-based chemotherapy (Parmar et al, 2003).
With regard to discrepancy of prognostic factor between clinical and histological response to CRT, the tumours with clinical PR was included in various histological effects, grades 1, 2, and 3.
In our analysis, patients receiving vaccine treatment experienced a few severe side effects (grades ≥3), but no statistical difference was observed compared with the corresponding control group (figure 5).
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If worse adverse effects (grade III or IV) occurred, treatment was interrupted until recovery.
As adverse effects, grade 1 or 2 drowsiness was seen in 26 patients.
In the AVAiL study, the incidence of adverse effects (grade 3 or higher) was similar among all groups.
During each cycle, patients were instructed to report the experienced side effects, graded as mild, moderate or severe.
Defined DLTs included: grade IV diarrhoea despite appropriate treatment with antidiarrhoea drugs; grade IV haematological side effects; grade IV mucositis; any other acute side effect at grade IV; severe nausea; vomiting 6 10 times a day despite the use of antiemetics.
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