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Property:Outcome specification

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Self-reported "complete response" ("no vomiting", "no clinically significant nausea", defined as nausea <2 on a 10-point scale, and "no use of emergency medication") during the acute (0-24 h), delayed (24-120 h) and general phase (0-120 h) of chemotherapy with diary day -1 to 6 of each cycle)  +
'''Mucositis''' Maximum extent: Evaluation for tissue responses for acute radiation side effects by grading mucositis at each visit Grade of mucosits: 0 = nil 1 = mild 2 = moderate 3 = severe Evaluation was continued at weekly intervals for 6 to 8 weeks covering the period of radiation therapy, and for another 5 to 6 month after the end of radiation therapy. The maximum score for the respective observation time were recorded. Grading was always done be the same investigator.  +
'''Onset of grade II side effects''' Secondary criteria for efficacy was the time to reach a certain grade after commencement of radiation therapy; only patients with complete data set: Enzyme-arm: N=50, control-arm: N=43  +
'''Skin reaction''' Maximum extent: Evaluation for tissue responses for acute radiation side effects by grading skin reactions at each visit Grade of skin reaction: 0 = nil 1 = erythema 2 = early desquamation/pigmentation 3 = moderate dry/ early moist desquamation 4 = blister formation/ skin peel Evaluation was continued at weekly intervals for 6 to 8 weeks covering the period of radiation therapy, and for another 5 to 6 month after the end of radiation therapy. The maximum score for the respective observation time were recorded. Grading was always done be the same investigator.  +
'''Area under curve''' Secondary criteria for efficacy were the areas under the curves in graphs for muscositis, skin reactions and dysphagia after commencement of radiation therapy. "Area under the curve" indicates the average score for muscositis, skin reactions and dysphagia; only patients with complete data set: Enzyme-arm: N=50, control-arm: N=43  +
'''Dysphagia ''' Maximum extent: Evaluation for tissue responses for acute radiation side effects by grading dysphagia at each visit Grade of dysphagia: 0 = nil 1 = for solids 2 = for semisolids 3 = for liquids 4 = requiring ryles tube/feeding gastrostomy Evaluation was continued at weekly intervals for 6 to 8 weeks covering the period of radiation therapy, and for another 5 to 6 month after the end of radiation therapy. The maximum score for the respective observation time were recorded. Grading was always done be the same investigator.  +
H