Trial Outcomes & Findings for AVODART(Dutasteride) Post-marketing Surveillance(PMS) (NCT NCT01299571)

Last Updated: 2017-07-05

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

3977 participants

Primary outcome timeframe

6 months

Results posted on

2017-07-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Avodart 0.5 mg Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily.
Overall Study STARTED	3977
Overall Study COMPLETED	3870
Overall Study NOT COMPLETED	107

Reasons for withdrawal

Reasons for withdrawal
Measure	Avodart 0.5 mg Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily.
Overall Study Protocol Violation	107

Baseline Characteristics

AVODART(Dutasteride) Post-marketing Surveillance(PMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avodart 0.5 mg n=3870 Participants Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
Age, Continuous	67.3 Years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3870 Participants n=5 Participants
Race/Ethnicity, Customized Korean	3870 participants n=5 Participants
Race/Ethnicity, Customized Not Korean	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Avodart 0.5 mg n=3870 Participants Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
Number of Participants With an Adverse Event	146 participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Avodart 0.5 mg n=3870 Participants Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
Number of Participants With a Serious Adverse Event	5 participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Avodart 0.5 mg n=3870 Participants Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
Number of Participants With the Indicated Unexpected Adverse Events Lung Carcinoma	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Insomnia	2 participants
Number of Participants With the Indicated Unexpected Adverse Events Mouth Dry	3 participants
Number of Participants With the Indicated Unexpected Adverse Events Constipation	2 participants
Number of Participants With the Indicated Unexpected Adverse Events Abdominal Pain	2 participants
Number of Participants With the Indicated Unexpected Adverse Events Diarrhea	2 participants
Number of Participants With the Indicated Unexpected Adverse Events Vomiting	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Colonic Polyp	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Epigastric Discomfort	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Gastroesophageal Reflux	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Hemorrhoids	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Asthenia	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Fever	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Chills	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Pain	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Spasms	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Orofacial Dyskinesia	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Embolism Pulmonary	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Thrombosis Cerebral	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Nose Congestion	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Pneumonia	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Skin Eruption	1 participants
Number of Participants With the Indicated Unexpected Adverse Events Thrombosis Venous Deep	1 participants

Adverse Events

Avodart 0.5 mg

Serious events: 5 serious events

Other events: 146 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Avodart 0.5 mg n=3870 participants at risk Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
Gastrointestinal disorders Diarrhea	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Respiratory, thoracic and mediastinal disorders Embolism Pulmonary	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Blood and lymphatic system disorders Thrombosis Cerebral	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.

Other adverse events

Other adverse events
Measure	Avodart 0.5 mg n=3870 participants at risk Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
Psychiatric disorders Impotence	1.9% 72/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Psychiatric disorders Libido Decreased	1.3% 49/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Reproductive system and breast disorders Ejaculation Disorder	0.78% 30/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Dyspepsia	0.16% 6/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Endocrine disorders Gynaecomastia	0.13% 5/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Mouth Dry	0.08% 3/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Psychiatric disorders Insomnia	0.05% 2/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Constipation	0.05% 2/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Abdominal Pain	0.05% 2/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Diarrhea	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Vomiting	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Colonic Polyp	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Epigastric Discomfort	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Gastroesophageal Reflux	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Gastrointestinal disorders Hemorrhoids	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Localized Edema	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Asthenia	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Allergy	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Fever	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Chills	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
General disorders Pain	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Nervous system disorders Dizziness	0.05% 2/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Nervous system disorders Spasms	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Nervous system disorders Orofacial Dyskinesia	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Respiratory, thoracic and mediastinal disorders Nose Congestion	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Skin and subcutaneous tissue disorders Skin Eruption	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Cardiac disorders Thrombosis Venous Deep	0.03% 1/3870 • 6 months Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER