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Property:Side Effects / Interactions

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6x gastrointestinal complaints with possible connection to the study medication, 1x gastrointestinal complaints with definite connection to the study medication; 5 participants subsequently discontinued the study  +
2x gastrointestinal side effects, 3x mild or moderate nausea, 1x nocturia, 1x dry skin, 1x urinary tract infection; 1x gastrointestinal complaints were definitely and 1x questionably attributable to the study medication, nocturia and dry skin were questionably related to the study medication, the urinary tract infection was not related to the medication; 2 participants subsequently discontinued the study  +
Survey by doctor and weekly diary entries by patients Side effects in the sinecatechins arm after 3/6/8 weeks in %: Erythema: 10/12/9 Edema: 2/6/3 Erosion: 5/7/4 Crusts: 3/10/6 Vesicles/Bullae: 3/3/2 Squamae:3/5/4 Itching: 10/13/12 Burning Sensation: 3/5/3 Use of the sinecatechins ointment led to a statistically significant higher frequency of erythema, edema, erosions, crusts, and itching than the use of placebo ointment.  +
Survey by doctor and weekly diary entries by patients Side effects in the placebo arm after 3/6/8 weeks in %: Erythema: 6/2/2 Edema: 0/0/0 Erosion: 1/0/0 Crusts: 2/0/0 Vesicles/Bullae: 0/1/0 Squamae:0/0/0 Itching: 3/0/1 Burning Sensation: 1/1/0 Use of the sinecatechins ointment led to a statistically significant higher frequency of erythema, edema,erosions, crusts, and itching than the use of placebo ointment.  +
No significant adverse event related to 6-gingerol observed, none of the patients withdrewn from the study due to toxicity/side ffects, no dose reduction required in either arm. 1 patient discontinued the study early due to 3rd degree vomiting requiring hospitalization - placebo-arm: n=2 patients due to discontinuation of Chemotherapy after cycle 2 or due to 2nd degree dyspepsia  +
No significant adverse event related to intervention observed, none of the patients withdrewn from the study due to toxicity/side ffects, no dose reduction required in either arm. 2 patients discontinued the study early due to discontinuation of Chemotherapy after cycle 2 or due to 2nd degree dyspepsia  +