4.Clarithromycin was well tolerated with only1% of patients discontinuing treatment due to drug-related adverse events.病人对克拉红霉素的耐受性良好,只有1%的病人因药物相关性不良事件而停药。 5.Discussion between adverse events and drug in Human tolerance test人体耐受性试验中不良事件与药物关系分析探讨 6...
Safety Any adverse event (AE) 141 (71) 145 (74) 0.86 Grade ≥3 study drug-related AE 8 (4) 10 (5) 0.65 Study drug-related serious adverse event (SAE) 3 (2) 4 (2) 0.73 AE leading to discontinuation 9 (5) 20 (10) 0.07 1Adjusted for baseline clinical status About the SIMPLE T...
(2016). Can social media data lead to earlier detection of drug-related adverse events? Pharmacoepidemiol. Drug Saf. 25, 1425-1433. doi: 10.1002/pds.4090Duh MS, Cremieux P, Audenrode MV, Vekeman F, Karner P, Zhang H, Greenberg P. Can social media data lead to earlier detection of ...
●Description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and of precautions or special monitoring to be done as part of the investigational use of...
adverse drug event Wikipedia (ad-vĕrs drug ĕ-vent'), "aninjuryresultingfrommedicalinterventionrelatedto adrug."[InstituteofMedicine] Seealso:adverse event. FarlexPartnerMedicalDictionary©Farlex2012 adverse drug reaction Anynoxiousandunintendedresponseassociatedwiththeuseof adruginhumans. ...
However, in certain circumstances, analyses of spontaneous reports can lead to an assessment that a drug and a usually relatively rare outcome are causally related. Criteria for such circumstances often include13 a temporal relationship between the drug and a rare (often drug-related) outcome, ...
related common lowbeforegoingtothemarketpredictabledecrementordiscontinuation B-type bizzare unrelated uncommon highaftergoingtothemarketunpredictable discontinuation B)据不良反应的性质分类 1.sidereaction2.toxicreaction3.residualeffect4.idiosyncraticreaction5.allergicreaction6.withdrawlreaction7.specialtoxicity ...
药物不良反应Adversedrugreaction第一节概述(introduction)“海豹肢畸形”婴儿一、基本概念 1.药物不良反应(adversedrugreaction,ADR)合格药品在正常用法用量下出现的与用药目的无关的或意外的有害反应,排除用药过量、用药不当所致的药物反应 2.药物不良事件(adversedrugevent,ADE)药物治疗期间所发生的任何不利的医疗事件,...
1、药物不良反应与药源性疾病Adversedrugreact第一节 概述(introduction)“海豹肢畸形海豹肢畸形”婴儿婴儿一、基本概念l1.药物不良反应(adverse drug reaction, ADR) 合格药品在正常用法用量下出现的与用药目的无关的或意外的有害反应,排除用药过量、用药不当所致的药物反应l2.药物不良事件(adverse drug event, ADE)...
test species, and the various study designs. Such databases are especially relevant for determining the cause of relatively rare and spontaneous adverse events, such as major fetal malformations, and can aid in the evaluation of any rare event th...