Benign Prostatic Hyperplasia, Prostatic Hyperplasia
Conditions
Brief summary
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information
Interventions
DRUGDutasteride
Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* The Korean BPH Patients administrated dutasteride according to the prescribing information
Exclusion criteria
* women and children and adolescents. * patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Adverse Event | 6 months | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Serious Adverse Event | 6 months | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record. |
| Number of Participants With the Indicated Unexpected Adverse Events | 6 months | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. |
Countries
South Korea
Participant flow
Recruitment details
The objective of this post-marketing surveillance (PMS) study was to assess the occurrence of adverse events reported after administration of Avodart in Korean benign prostatic hyperplasia (BPH) patients.
Participants by arm
| Arm | Count |
|---|---|
| Avodart 0.5 mg Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily | 3,870 |
| Total | 3,870 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 107 |
Baseline characteristics
| Characteristic | Avodart 0.5 mg |
|---|---|
| Age, Continuous | 67.3 Years STANDARD_DEVIATION 9.1 |
| Race/Ethnicity, Customized Korean | 3870 participants |
| Race/Ethnicity, Customized Not Korean | 0 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3870 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 146 / 3,870 |
| serious Total, serious adverse events | 5 / 3,870 |
Outcome results
Primary
Number of Participants With an Adverse Event
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record.
Time frame: 6 months
Population: Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avodart 0.5 mg | Number of Participants With an Adverse Event | 146 participants |
95% CI: [3.2, 4.4]
Secondary
Number of Participants With a Serious Adverse Event
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record.
Time frame: 6 months
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avodart 0.5 mg | Number of Participants With a Serious Adverse Event | 5 participants |
Secondary
Number of Participants With the Indicated Unexpected Adverse Events
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
Time frame: 6 months
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Nose Congestion | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Pneumonia | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Lung Carcinoma | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Skin Eruption | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Thrombosis Venous Deep | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Vomiting | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Colonic Polyp | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Epigastric Discomfort | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Gastroesophageal Reflux | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Hemorrhoids | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Asthenia | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Fever | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Chills | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Pain | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Spasms | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Orofacial Dyskinesia | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Embolism Pulmonary | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Thrombosis Cerebral | 1 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Constipation | 2 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Abdominal Pain | 2 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Insomnia | 2 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Mouth Dry | 3 participants |
| Avodart 0.5 mg | Number of Participants With the Indicated Unexpected Adverse Events | Diarrhea | 2 participants |