Safety Outcomes
Conditions
Brief summary
This study is conducted to meet the requirements of the Drug Administration of Vietnam (DAV) on conducting necessary safety evaluations in routine clinical practice for a new medication within 3 years from its date of approval. For the case of the study treatment (dapagliflozin - Forxiga), safety and drug utilization reports have been regularly submitted by AstraZeneca to DAV every 6 months since its date of approval on 25th May 2016. To provide additional evidence on the safety profile of dapagliflozin in real-life settings and support renewing marketing authorizations for Forxiga, AstraZeneca collaborated with eight hospitals across Vietnam to implement this study.
Detailed description
This study is a longitudinal observation on a cohort of 1001 patients with type 2 diabetes mellitus (T2DM), newly treated with dapagliflozin at eight hospitals across Vietnam. Adult T2DM patients who were newly treated with dapagliflozin and signed the informed consent form were eligibly recruited. For each recruited subject, the maximum duration of observation was 24 weeks, divided into 4 visits. In the first visit, data on subjects' baseline characteristics was collected. In the later visits, the presence, and the patterns of adverse events during the time treated with dapagliflozin were investigated.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥ 18 years) * Diagnosed with T2DM, and eligible for initiating treatment with dapagliflozin according to indications of the approved summary of product characteristics of Forxiga in Vietnam. * Provision of signed and dated written informed consent form by the potential study subject or the subject's legal guardian to demonstrate that s/he was informed necessary information of this study, prior to any mandatory study specific procedures
Exclusion criteria
* Patients who were prescribed dapaglifozin for off-label use (not mentioned in the approved summary of product characteristics of Forxiga in Vietnam) * Patients who had contraindications with Forxiga
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual incidence rate and proportions of AE, SAE, and sAR within 24 weeks | 24 weeks | Monitoring and reporting data on adverse events (AEs) and serious adverse events (SAEs) during the treatment with dapagliflozin was implemented consistently with routine care in each studied site. For the patients discontinued dapagliflozin before completing the standard follow-up period (24 weeks), data would be collected via phone calls or emails. Decisions of continuing or discontinuing dapagliflozin treatment, either related or unrelated with safety issues, were completely depended on the medical doctor's opinion, with the patient's agreement |
Countries
Vietnam
Outcome results
None listed