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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dutasteride | Patients administrated dutasteride at the site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutasteride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The Korean BPH Patients administrated dutasteride
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Seoul | 110-749 | South Korea |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avodart 0.5 mg | Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Avodart 0.5 mg | Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had completed safety assessments. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments | Posted | Number | participants | 6 months |
|
6 months
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avodart 0.5 mg | Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | WHOART | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impotence | Psychiatric disorders | WHOART | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| 6 months |
| 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. | 6 months |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had completed safety assessments. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had completed safety assessments. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | ITT Population | Posted | Number | participants | 6 months |
|
|
|
| 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. | ITT Population | Posted | Number | participants | 6 months |
|
|
|
| 5 |
| 3,870 |
| 146 |
| 3,870 |
| Embolism Pulmonary | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Thrombosis Cerebral | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Lung Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
|
| Libido Decreased | Psychiatric disorders | WHOART | Systematic Assessment |
|
| Ejaculation Disorder | Reproductive system and breast disorders | WHOART | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Gynaecomastia | Endocrine disorders | WHOART | Systematic Assessment |
|
| Mouth Dry | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | WHOART | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Colonic Polyp | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Epigastric Discomfort | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Gastroesophageal Reflux | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Localized Edema | General disorders | WHOART | Systematic Assessment |
|
| Asthenia | General disorders | WHOART | Systematic Assessment |
|
| Allergy | General disorders | WHOART | Systematic Assessment |
|
| Fever | General disorders | WHOART | Systematic Assessment |
|
| Chills | General disorders | WHOART | Systematic Assessment |
|
| Pain | General disorders | WHOART | Systematic Assessment |
|
| Dizziness | Nervous system disorders | WHOART | Systematic Assessment |
|
| Spasms | Nervous system disorders | WHOART | Systematic Assessment |
|
| Orofacial Dyskinesia | Nervous system disorders | WHOART | Systematic Assessment |
|
| Nose Congestion | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Skin Eruption | Skin and subcutaneous tissue disorders | WHOART | Systematic Assessment |
|
| Thrombosis Venous Deep | Cardiac disorders | WHOART | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D052801 |
| Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Abdominal Pain |
|
| Diarrhea |
|
| Vomiting |
|
| Colonic Polyp |
|
| Epigastric Discomfort |
|
| Gastroesophageal Reflux |
|
| Hemorrhoids |
|
| Asthenia |
|
| Fever |
|
| Chills |
|
| Pain |
|
| Spasms |
|
| Orofacial Dyskinesia |
|
| Embolism Pulmonary |
|
| Thrombosis Cerebral |
|
| Nose Congestion |
|
| Pneumonia |
|
| Lung Carcinoma |
|
| Skin Eruption |
|
| Thrombosis Venous Deep |
|