GSK medicine : rosiglitazone/metformin Study No.: 105709 Title : An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of Avandamet® administered in Korean Diabetic patients according to the
prescribing information Rationale :This PMS collected routine clinical data in the local target population (600 subjects) as per the requirement of Korean Food and Drug Administration (KFDA). Objectives: The objective of this post-marketing surveillance (PMS) is to monitor safety and
efficacy of Avandamet® under the real clinical setting after launch. Indication: Non-insulin-dependent diabetes mellitus(Type II Diabetes Mellitus) Study investigators/Centers : GSK conducted study, 8 centres & 10 investigators in South Korea Research Methods : Data source : Standardized hard copy Case Report Form(CRF) Study Design : Open label, multi-center, non-interventional post-marketing surveillance. Study population : Male and female subjects who were considered appropriate to prescribe
Avandamet® according to the prescribing information were eligible for this study. Subjects who had previously been treated with Avandamet® were not eligible for this study.
Planned, N (according to the legal requirement by KFDA)
Total Number Subjects Withdrawn, n (%)11(1.5%)
Withdrawn due to Lack of Efficacy n (%)0 (0.0%)
Study Exposures, Outcomes : Primary outcome/ Efficacy Variable(s): observed incidence of adverse events in Korean Type II
DM patients treated with Avandamet® based on prescribing information under the real clinical setting .
Secondary Outcome//Efficacy Variable(s): to identify risk factors associated with the occurrence of adverse events. ‘Ex pected’ was that adverse events were described in the locally approved
label by KFDA at the time the Korean PMS was ended. ‘Un expected’ included events which were not described in the locally approved label by KFDA at the time of surveillance completion. Data Analysis Methods : Since this study was not designed to test any statistical hypothesis, basically descriptive statistics were presented. Data were summarized using simple summary
statistics for example means and counts, at each individual. Adverse events were coded by using WHOART (preferred term level) according to the local regulation. The cumulative
incidence of adverse event was estimated with 95% confidence interval. In addition, the incidence of unexpected adverse event and the incidence of serious adverse events were
computed. Chi-square test or Fisher’s exact test were performed to identify risk factor associated with the occurrence of adverse events. Limitations : As being observation study, there was no comparison group. Study Results : Demographics N (ITT safety population) Primary Results: (ITT Safety population) Overall incidence of adverse events, n (%)
Exact 95% Confidence interval for overall (3.00, 6.07)
Secondary Outcome Variable(s): (Safety ITT population) Summary of risk factors by incidence of Adverse events, n(%)
adverse events Covariates 32 (4.57%) 668 (95.43%) Safety Results: Most Frequent Adverse Events – On- Avandamet®(N=706) Therapy, n(%) Subjects with any AE(s), n(%) HEADACHE Serious Adverse Events – On-Therapy Avandamet®(N=706) n(%), [n considered by the investigator to be related to study medication] Subjects with any SAE(s), n(%) [includes SAE 0 (0.00%), [0(0.00%)] related to Avandamet®] Conclusion: 34 Adverse events were reported in 32 subjects, the most frequent being Oedema. The overall incidence of adverse events was 4.53% (95% CI: 3.00-6.07). A total of 12
unexpected adverse events were reported in 11 subjects. The incidence of unexpected adverse events was 1.56%. There was no serious adverse event in the surveillance.
1. Premessa Le comunità cristiane non possono fare a meno di gioire perché sono chiamate a rendere testimonianza della propria fede in Gesù Cristo risorto che trasforma la vita dell’uomo e del mondo in una festa continua. E’ stato scritto che: "la nostra esistenza di cristiani consiste nel vivere continuamente il mistero pasquale: piccole morti successive seguite dai segni di u
For guidance on the completion of this template, refer to Section 2.6 in Chapter 2 of Part 2 of this Handbook. College/Department A Field Experience Course Identification and General Information 1. Field experience course title and code 2. Credit hours 3. Program in which this field experience activity is offered 4. Name of faculty member responsible for administration of the fiel