serious adverse experience

serious adverse experience

In a clinical trial, any experience related to a therapeutic intervention that suggests a significant hazard, contraindication, side effect or the need for precautionary measures.
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Hematochezia reported as a serious adverse experience occurred in <0.
The most common serious adverse experience was bronchiolitis, which occurred in 1.
Seizures reported as serious adverse experiences occurred in <0.
6% of all subjects who reported a pregnancy in the respective vaccination groups), experienced a serious adverse experience during pregnancy.
8% of the total number of subjects who were breast-feeding during the period in which they received GARDASIL or placebo, respectively), experienced a serious adverse experience.
A total of 102 subjects out of 21,464 total subjects (9- to 26-year-old girls and women and 9- to 15-year-old boys) who received both GARDASIL and placebo reported a serious adverse experience on Day 1-15 following any vaccination visit during the clinical trials for GARDASIL.
Finally, there is a series of annexes dealing with geographical distribution of lymphatic filariasis, onchocerciasis, schistosomiasis and soil transmitted helminthiasis, strategies for rapid assessment, standardized forms for recording serious adverse experiences, drug supply, recommended dosages and dose poles, coverage forms and disease specific information.
6% of each group discontinued the medication due to serious adverse experiences.
The data also showed fewer and less serious adverse experiences reported in both HepeX-B groups as compared to the HBIg group, although the differences were not statistically significant given the number of patients in the trial.
No serious adverse experiences were seen in this trial, nor was kidney function adversely affected in any patient.
There were no serious adverse experiences noted that appear to be related to SuperVent(TM).