个体受试者实验室检查结果和异常值

玫瑰 2018年11月17日 19:42
翻译习作

12.4个体受试者实验室检查结果和异常值
受试者血常规仅2例受试者出现异常,113号受试者出现嗜酸性粒细胞百分比上升和嗜碱性粒细胞百分比上升,216号受试者出现中性粒细胞下降和白细胞计数下降。血生化异常情况包括血尿酸升高、空腹血糖下降和甘油三酯升高。受试者血常规、血生化、尿常规、凝血检查结果和异常值,详见附件12统计分析报告列表16.8.2.1.1-3、16.2.8.2。

12.5生命体征、体格检查和心电图
试验过程中未出现生命体征、体格检查的异常。仅1例受试者出现十二导联心电图异常,判断为连接性心律失常,发生在给药后2天,持续时间为51分钟,未干预后痊愈,研究者判断为与药物有合理可能性。

12.6安全性结论
在使用MP-513(20mg)的受试者中,7例(43.8%)受试者至少出现一次不良事件,6例(37.5%)受试者至少出现一次药品不良反应。在该组受试者中没有出现死亡、严重不良事件和严重药品不良反应;在使用MP-513(40mg)的受试者中,5例(31.3%)受试者至少出现一次不良事件和至少一次药品不良反应。1例(6.3%)受试者出现严重不良事件和严重药品不良反应。在该组受试者中没有出现死亡事件;在使用MP-513(80mg)的受试者中,5例(31.3%)受试者至少出现一起不良事件和至少一起药品不良反应。在该组受试者中没有出现死亡和严重药品不良反应。20mg剂量组生命体征测量和实验室检验均无超出正常范围且具有临床显著性的结果。全部受试者的AE均恢复至正常。无受试者因为不良事件退出试验。AE发生率与给药剂量和全身暴露量不相关。

12 4 The laboratory test result and outlines for indivdual subjects
Only 2 subjects showed abnormal blood routine,No .113 subject showed increased eosinophil percentage and increased basophil percentage,No. 216 subject showed the amount of neutrophils decreasing and that of leukocytes decreasing Biochemical abnormalities include blood uric acid araising. FBG decreasing and triglycerides araising .Blood routine, blood blochemical, urine routine, coagulationtest results and abnormal values of the subjects are shown in appendix 12 statisticalanalysis report table 16.8.2.1.1-3 and 16.2.8.2

12.5 Vital signs, physical examination, and ecg
The test didn't show abnormal vital signs and physical examination.Only 1 subject showed abnormal 12 lead ECG,judging as connective arthythmia,happening affer 2 days of giving the medicine,with a duration of 51 minutes and recovery afterno intervention, the researchers determined that there was a reasonable possibilitywith the drug.

12.6 Security conclusion
Of the subjects using mp-513 (20mg) 7 subjects(43.8 percent) had at least one adverse event and 6 subjects (37.5 percent) had at least one adverse drug reaction.There were no deaths, serious adverse events, or serious adverse drug reactions among the subjects in this group of the subjects using mp-513 (40mg). 5 subjects(31.3 percent) had at least one adverse event and drug reaction,and 1 subject(6.3 percent) had serious adverse events and drug reaction.There were no deaths. Of the subjects using mp-513 (80mg) 5 subjects(31 3 percent) had at least one adverse event and drug reaction There were no deaths or serious adverse drug reactions among the subjects in this group .The vital signs measurements and laboratory tests in the 20mg dose group were not out of the normal range and had cinical significance. All subjects AE returned to nomal .No subjects withdrew from the trial because of adverse events. The incidence of AE was not relaled to dose and systemic exposure.

0 likes