Treatment was also discontinued in the case of severe hypersensitivity reaction, grade 3 or 4 PPE or mucositis persisting for >2 weeks, reduction of LVEF >20% from baseline value, in the case of symptomatic congestive heart failure, or in any case of >G3 non-haematological toxicity (with the exception of alopecia or nausea/vomiting).
The sorafenib-related adverse events consisted of grade 3 hand-foot skin reaction, grade 2 alopecia, tinnitus, and diarrhea.
Judgment of vomiting grade was based on WHO toxicity reaction: grade 0: no nausea and vomiting; grade I: nausea; grade II: casual vomiting, not requiring medication; grade III: frequent vomiting, requiring medication; grade IV: serious vomiting, uncontrolled with medication.
The scar grade based on the report of Maeshima et al. is recorded routinely in our hospital in the pathological records as an index of fibrosis in adenocarcinoma: grade 1, adenocarcinoma without a desmoplastic reaction; grade 2, sparse desmoplastic reaction; grade 3, dense desmoplastic reaction with diameter of ≤10 mm; grade 4, dense desmoplastic reaction with diameter >10 mm.
Exclusion criteria also consisted of a history of severe allergic reactions (grade III or IV or grade II not responsive to corticosteroids) attributed to medications containing Cremophor.
Nonhaematological toxicities were mild, 23 episodes of hypersensitivity and/or cutaneous reactions grade 3/4.
With variation of reaction conditions/factors, various grades of crosslinked hydrogels/nanocomposites have been synthesized and optimized on the basis of lower % swelling and higher % crosslinking.
Furthermore, consideration of the organ reaction and grade of changes were examined by calculating organ index (OX) of each organ separately.
Among the 36 patients receiving the drug via peripheral veins, 13 developed mild injection site reactions of grade 1 or 2; no grade 3 reactions were observed.
Neither it was possible to identify between a minor (n = 8) group of retrospectively identified RC patients with an adverse clinical GI reaction of grade 3 to RT and patients with grade 2 or normally-reacting RC patients.
