The purpose of this study is to describe the following in relation to the safety of
Equfina Tablet 50 mg in the post marketing setting: 1. Serious adverse events (SAEs) and
adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected
in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy
related information.

A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg)

Parkinson Disease

Equfina 50 mg

Equfina Tablet 50 mg Post Marketing Surveillance Protocol

A SAE is defined as any untoward medical occurrence: resulting in death; life threatening
requiring hospitalization or prolongation of hospitalization; resulting in persistent or
significant disability or incapacity; resulting in birth defect or congenital anomaly or
medically important due to other reasons than above mentioned criteria.

An ADR is defined as harmful and unintended responses to the normal administration/use of
drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs
with unknown causality to the drug among those voluntarily reported will be also
considered ADRs.

An AE is defined as any untoward and unintended signs (example, anomalies in laboratory
test results) or symptoms/diseases occurring during administration/use of drugs, which do
not necessarily have a causal relationship with the drug in question. An unexpected AE is
an AE with a difference in nature, severity, specificity, or outcome, compared to the
product licensure/safety notification of the drug.

An ADR is defined as harmful and unintended responses to the normal administration/use of
drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs
with unknown causality to the drug among those voluntarily reported will be also
considered ADRs. An unexpected ADR is an ADR with difference in the nature or severity,
specificity, or the outcome, compared to the product licensure/notification of the drug.

An ADR is defined as harmful and unintended responses to the normal administration/use of
drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs
with unknown causality to the drug among those voluntarily reported will be also
considered ADRs. Known ADRs are those listed in product licensure/notification of the
drug.

The CGIC is a 7-point scale that measures a physician's global impression of a
participant's clinical condition. Scale ranges from 1 to 7 with lower scores indicating
improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores
indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score
of 4 indicating no change.

Participants who will be prescribed with Equfina 50 mg tablets, orally within the scope
of the approved label for Korea under the medical judgment of the investigator will be
observed prospectively for 24 weeks.

A Post Marketing Surveillance Study of Equfina Tablet 50 Milligram (mg)

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status