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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6% of all subjects who reported a pregnancy in the respective vaccination groups), experienced a serious adverse experience during pregnancy.
The serious adverse experience information for these subjects is provided in this circular (see ADVERSE REACTIONS).
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.
According to the clinical study protocol to evaluate safety, all study subjects were followed after each vaccine dose for all serious adverse experiences ("SAEs"), including intussusception.
This analysis was based on an independent safety endpoint evaluation committee's (SEEC) blinded review of each patient's case report form and medical records, including adverse and serious adverse experiences, vital signs, ECG results, clinical laboratory tests, and physical and neurological examination results.
Terry Williams, Director of Development of MoliChem said, "The four month Phase I clinical trial of four doses in aerosol showed no serious adverse experiences, indeed no events of clinical significance.
The most common side effect from the drug reported in the studies was sweating; no serious adverse experiences were reported.
No serious adverse experiences related to Procysteine(R) have been reported in studies to date.
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.