Trial Outcomes & Findings for Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH) (NCT NCT00527605)
NCT ID: NCT00527605
Last Updated: 2012-03-21
Results Overview
Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
253 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2012-03-21
Participant Flow
Participant milestones
| Measure |
Dutasteride 0.5 mg
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
127
|
|
Overall Study
COMPLETED
|
113
|
116
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
Reasons for withdrawal
| Measure |
Dutasteride 0.5 mg
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
|
Overall Study
Lost to Follow-up
|
6
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
Baseline Characteristics
Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
Baseline characteristics by cohort
| Measure |
Dutasteride 0.5 mg
n=126 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=127 Participants
Matching oral placebo once a day for 6 months
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
65.8 years
STANDARD_DEVIATION 7.7 • n=93 Participants
|
66.9 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
66.4 years
STANDARD_DEVIATION 7.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=93 Participants
|
127 Participants
n=4 Participants
|
253 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
126 participants
n=93 Participants
|
127 participants
n=4 Participants
|
253 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment (after the 4-week placebo run-in) and received at least one dose of study treatment. Some participants were missing Month 6 measurements.
Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=114 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=120 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Percent Change From Baseline in the Prostate Volume at Month 6
|
-17.00 percent change in volume
Standard Deviation 21.41
|
-2.77 percent change in volume
Standard Deviation 24.96
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: ITT Population. Some participants were missing Month 3 measurements.
Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=112 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=118 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Percent Change From Baseline in the Prostate Volume at Month 3
|
-12.02 percent change in volume
Standard Deviation 23.22
|
-1.02 percent change in volume
Standard Deviation 25.79
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Some participants were missing Month 6 measurements.
Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=114 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=120 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Change From Baseline in the Prostate Volume at Month 6
|
-9.16 cubic centimeters
Standard Deviation 12.74
|
-1.20 cubic centimeters
Standard Deviation 12.77
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: ITT Population. Some participants were missing Month 3 measurements.
Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=112 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=118 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Change From Baseline in the Prostate Volume at Month 3
|
-7.11 cubic centimeters
Standard Deviation 13.02
|
-1.06 cubic centimeters
Standard Deviation 11.48
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Some participants were missing Month 6 measurements.
Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=114 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=121 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6
|
-52.53 percent change
Standard Deviation 44.42
|
26.78 percent change
Standard Deviation 149.07
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: ITT Population. Some participants were missing Month 3 measurements.
Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=114 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=120 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Percent Change From Baseline in the Serum DHT at Month 3
|
-59.15 percent change
Standard Deviation 37.90
|
28.33 percent change
Standard Deviation 133.71
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Some participants were missing Month 6 measurements.
Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=114 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=121 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Change From Baseline in the Serum DHT at Month 6
|
-289.175 picograms/milliliter (pg/ml)
Standard Deviation 270.610
|
-46.099 picograms/milliliter (pg/ml)
Standard Deviation 399.806
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: ITT Population. Some participants were missing Month 3 measurements.
Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=114 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=120 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Change From Baseline in the Serum DHT at Month 3
|
-319.605 pg/ml
Standard Deviation 256.058
|
-34.400 pg/ml
Standard Deviation 399.633
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Some participants were missing Month 6 measurements.
Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=113 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=121 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6
|
-26.48 percent change
Standard Deviation 26.01
|
-20.79 percent change
Standard Deviation 30.18
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: ITT Population. Some participants were missing Month 3 measurements.
Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=113 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=121 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Percent Change From Baseline in the AUA-SI Score at Month 3
|
-15.64 percent change
Standard Deviation 24.59
|
-11.91 percent change
Standard Deviation 21.55
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Some participants were missing Month 6 measurements.
Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=113 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=121 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Change From Baseline in the AUA-SI Score at Month 6
|
-4.9 points on a scale
Standard Deviation 4.8
|
-4.1 points on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: ITT Population. Some participants were missing Month 3 measurements.
Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=113 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=121 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Change From Baseline in the AUA-SI Score at Month 3
|
-2.9 points on a scale
Standard Deviation 3.9
|
-2.4 points on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Some participants were missing Month 6 measurements.
Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=113 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=119 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6
|
16.14 percent change
Standard Deviation 57.43
|
6.31 percent change
Standard Deviation 47.55
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: ITT Population. Some participants were missing Month 3 measurements.
Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=111 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=117 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Percent Change From Baseline in Qmax at Month 3
|
14.34 percent change
Standard Deviation 42.86
|
5.85 percent change
Standard Deviation 34.69
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Some participants were missing Month 6 measurements.
Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=113 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=119 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Change From Baseline in Qmax at Month 6
|
0.75 milliliters/second (ml/s)
Standard Deviation 5.61
|
0.03 milliliters/second (ml/s)
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: ITT Population. Some participants were missing Month 3 measurements.
Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.
Outcome measures
| Measure |
Dutasteride 0.5 mg
n=111 Participants
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=117 Participants
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Change From Baseline in Qmax at Month 3
|
0.93 ml/s
Standard Deviation 4.74
|
0.17 ml/s
Standard Deviation 4.56
|
Adverse Events
Dutasteride 0.5 mg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dutasteride 0.5 mg
n=126 participants at risk
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=127 participants at risk
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Eye disorders
Glaucoma
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
Other adverse events
| Measure |
Dutasteride 0.5 mg
n=126 participants at risk
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
|
Placebo
n=127 participants at risk
Matching oral placebo once a day for 6 months
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Eye disorders
Dry eye
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Eye disorders
Keratitis
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
1.6%
2/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Dry mouth
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Dysgeusia
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Pharyngitis
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Stomach discomfort
|
2.4%
3/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
2.4%
3/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Throat irritation
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Infections and infestations
Erysipelas
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Infections and infestations
Alanine aminotransferase increased
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Infections and infestations
Aspartate aminotransferase increased
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Infections and infestations
Blood glucose increased
|
1.6%
2/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Infections and infestations
Prostatic specific antigen increased
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Infections and infestations
White blood cell count decreased
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Infections and infestations
Red blood cells urine
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Infections and infestations
Transaminases increased
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
1.6%
2/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Musculoskeletal and connective tissue disorders
Contusion
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Nervous system disorders
Tinnitus
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Nervous system disorders
Vertigo
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Renal and urinary disorders
Urinary retention
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Reproductive system and breast disorders
Breast pain
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Reproductive system and breast disorders
Libido decreased
|
2.4%
3/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
1.6%
2/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
2.4%
3/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.6%
2/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.4%
3/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
3.9%
5/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.79%
1/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.79%
1/126 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
0.00%
0/127 • The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
|
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