Analysis of 233 Cases of Severe Adverse Events in Drug Clinical Trials of Our Hospital

VernacularTitle:我院药物临床试验中严重不良事件报告233例分析
Author: Tianxiang ZHANG ; Mingying LU ; Caixia ZHANG ; Zuyi YUAN
Publication Type:Journal Article
Keywords: Severe adverse events; Drug clinical trials; Subjects; Analysis
From: China Pharmacy 2016;27(23):3210-3211,3212
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To provide reference for performing quality control and protecting the subjects’rights and interests. METHODS:233 severe adverse events (SAE) cases reported by our hospital during Jan. 2012-Jun. 2015 were collected and ana-lyzed statistically in respects of subjects’gender and age,department,drug/equipment types,SAE types,relationship of SAE with drug/equipment,comorbidities,etc. RESULTS:The incidence of SAE in male was higher than female(71.2% vs. 28.8%);SAE mainly occurred in people over the age of 50(189 cases,81.1%);the incidence of SAE in cardiology department was the highest (137 cases,58.8%);main SAE type was hospitalization(183 cases,78.5%);most of SAE had nothing to do with studied drugs (164 cases,70.4%);more than half of the subjects suffered from other comorbidities(128 cases,54.9%). CONCLUSIONS:In order to ensure the quality of drug clinical trial data and safety of subjects,the investigator should strengthen the management of the elderly subjects and those suffering from comorbidities,to ensure that each SAE case is timely processed and accurately record-ed and reported.