Trial Outcomes & Findings for Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment (NCT NCT00090103)
NCT ID: NCT00090103
Last Updated: 2017-02-28
Results Overview
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4844 participants
Primary outcome timeframe
Years 1, 2, 3, and 4
Results posted on
2017-02-28
Participant Flow
In a 4-week, single-blind placebo run-in period, all participants (par.) took two capsules consisting of one dutasteride-matched placebo capsule and one tamsulosin-matched placebo capsule once daily for 4 weeks. A safety follow-up was performed for all participants 16 weeks after the last dose of study drug.
Participant milestones
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Four-Year Double-Blind Treatment Period
STARTED
|
1610
|
1623
|
1611
|
|
Four-Year Double-Blind Treatment Period
COMPLETED
|
1113
|
1093
|
989
|
|
Four-Year Double-Blind Treatment Period
NOT COMPLETED
|
497
|
530
|
622
|
|
16-Week Safety Follow-up Period
STARTED
|
1598
|
1615
|
1600
|
|
16-Week Safety Follow-up Period
COMPLETED
|
1224
|
1205
|
1143
|
|
16-Week Safety Follow-up Period
NOT COMPLETED
|
374
|
410
|
457
|
Reasons for withdrawal
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Four-Year Double-Blind Treatment Period
Adverse Event
|
211
|
185
|
210
|
|
Four-Year Double-Blind Treatment Period
Withdrawal by Subject
|
114
|
160
|
148
|
|
Four-Year Double-Blind Treatment Period
Lost to Follow-up
|
53
|
48
|
58
|
|
Four-Year Double-Blind Treatment Period
Protocol Violation
|
29
|
29
|
34
|
|
Four-Year Double-Blind Treatment Period
Lack of Efficacy
|
53
|
71
|
104
|
|
Four-Year Double-Blind Treatment Period
Participant Relocated
|
7
|
2
|
8
|
|
Four-Year Double-Blind Treatment Period
Site Closed/Sponsor Termination
|
7
|
7
|
4
|
|
Four-Year Double-Blind Treatment Period
Non-compliant/Medication Interruption
|
6
|
4
|
7
|
|
Four-Year Double-Blind Treatment Period
Prostate Surgery/TURP/Alt. Therapy
|
3
|
7
|
19
|
|
Four-Year Double-Blind Treatment Period
Participant Decision/Withdrawn
|
2
|
0
|
4
|
|
Four-Year Double-Blind Treatment Period
Acute Urinary Retention (AUR)
|
2
|
3
|
6
|
|
Four-Year Double-Blind Treatment Period
Prohibited Medication
|
2
|
2
|
8
|
|
Four-Year Double-Blind Treatment Period
Investigator Departure
|
2
|
0
|
0
|
|
Four-Year Double-Blind Treatment Period
Alcohol Dependent
|
1
|
0
|
0
|
|
Four-Year Double-Blind Treatment Period
Screen Failure
|
1
|
0
|
0
|
|
Four-Year Double-Blind Treatment Period
No Improvement
|
1
|
0
|
0
|
|
Four-Year Double-Blind Treatment Period
BPH/BPH symptoms worse/urinary incont.
|
1
|
0
|
5
|
|
Four-Year Double-Blind Treatment Period
Financial Problems
|
1
|
0
|
0
|
|
Four-Year Double-Blind Treatment Period
Loss of Libido
|
1
|
0
|
0
|
|
Four-Year Double-Blind Treatment Period
Angina Pectoris
|
0
|
2
|
0
|
|
Four-Year Double-Blind Treatment Period
Loss of Contact
|
0
|
1
|
0
|
|
Four-Year Double-Blind Treatment Period
Neoplasm of Bladder/Prostate
|
0
|
1
|
1
|
|
Four-Year Double-Blind Treatment Period
Cardiologist/Neurologist Decision
|
0
|
2
|
0
|
|
Four-Year Double-Blind Treatment Period
Renal Insufficiency
|
0
|
1
|
0
|
|
Four-Year Double-Blind Treatment Period
Back Pain
|
0
|
1
|
0
|
|
Four-Year Double-Blind Treatment Period
Scheduling Issues
|
0
|
1
|
0
|
|
Four-Year Double-Blind Treatment Period
Any Appreciable Improvement
|
0
|
1
|
0
|
|
Four-Year Double-Blind Treatment Period
Investigator Decision
|
0
|
1
|
3
|
|
Four-Year Double-Blind Treatment Period
Enrollment Error
|
0
|
0
|
2
|
|
Four-Year Double-Blind Treatment Period
Urinary Tract Infection (UTI)
|
0
|
0
|
1
|
|
Four-Year Double-Blind Treatment Period
Prostate Specific Antigen Rising
|
0
|
1
|
0
|
|
16-Week Safety Follow-up Period
Adverse Event
|
34
|
39
|
44
|
|
16-Week Safety Follow-up Period
Withdrawal by Subject
|
185
|
212
|
229
|
|
16-Week Safety Follow-up Period
Lost to Follow-up
|
101
|
97
|
111
|
|
16-Week Safety Follow-up Period
Protocol Violation
|
18
|
18
|
17
|
|
16-Week Safety Follow-up Period
Site Closed/Sponsor Termination
|
8
|
5
|
4
|
|
16-Week Safety Follow-up Period
Non-compliant/Medication Interruption
|
8
|
6
|
4
|
|
16-Week Safety Follow-up Period
Loss of Contact
|
4
|
0
|
2
|
|
16-Week Safety Follow-up Period
Disease Progression/Treatment Failure
|
3
|
1
|
1
|
|
16-Week Safety Follow-up Period
Participant relocated
|
2
|
3
|
1
|
|
16-Week Safety Follow-up Period
Participant Decision/Withdrawn
|
2
|
1
|
2
|
|
16-Week Safety Follow-up Period
Prohibited Medication
|
2
|
3
|
5
|
|
16-Week Safety Follow-up Period
Alcohol Dependent
|
1
|
0
|
1
|
|
16-Week Safety Follow-up Period
Prostate surgery/TURP/Alt. therapy
|
1
|
5
|
13
|
|
16-Week Safety Follow-up Period
Loss of Libido
|
1
|
0
|
0
|
|
16-Week Safety Follow-up Period
Enrollment Error
|
1
|
0
|
2
|
|
16-Week Safety Follow-up Period
Neoplasm of Bladder/Prostate Cancer
|
1
|
3
|
6
|
|
16-Week Safety Follow-up Period
Death
|
1
|
0
|
1
|
|
16-Week Safety Follow-up Period
Gyneomastia
|
1
|
0
|
0
|
|
16-Week Safety Follow-up Period
Acute Urinary Retention (AUR)
|
0
|
5
|
4
|
|
16-Week Safety Follow-up Period
BPH/BPH symptoms worse/urinary incont.
|
0
|
2
|
3
|
|
16-Week Safety Follow-up Period
Angina Pectoris
|
0
|
1
|
0
|
|
16-Week Safety Follow-up Period
Back Pain
|
0
|
1
|
0
|
|
16-Week Safety Follow-up Period
Scheduling Issues
|
0
|
2
|
4
|
|
16-Week Safety Follow-up Period
Investigator/Sponsor Decision
|
0
|
2
|
3
|
|
16-Week Safety Follow-up Period
Depression
|
0
|
1
|
0
|
|
16-Week Safety Follow-up Period
Diabetes Uncontrolled
|
0
|
1
|
0
|
|
16-Week Safety Follow-up Period
Jailed
|
0
|
1
|
0
|
|
16-Week Safety Follow-up Period
Other
|
0
|
1
|
0
|
Baseline Characteristics
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
Baseline characteristics by cohort
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1610 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1623 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1611 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
Total
n=4844 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 7.05 • n=5 Participants
|
66.0 years
STANDARD_DEVIATION 6.99 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 7.00 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 7.01 • n=4 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Gender
Male
|
1610 Participants
n=5 Participants
|
1623 Participants
n=7 Participants
|
1611 Participants
n=5 Participants
|
4844 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
1421 participants
n=5 Participants
|
1433 participants
n=7 Participants
|
1405 participants
n=5 Participants
|
4259 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
22 participants
n=5 Participants
|
17 participants
n=7 Participants
|
24 participants
n=5 Participants
|
63 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
107 participants
n=5 Participants
|
106 participants
n=7 Participants
|
112 participants
n=5 Participants
|
325 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Hispanic
|
44 participants
n=5 Participants
|
48 participants
n=7 Participants
|
55 participants
n=5 Participants
|
147 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
16 participants
n=5 Participants
|
19 participants
n=7 Participants
|
15 participants
n=5 Participants
|
50 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Years 1, 2, 3, and 4Population: Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1610 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1623 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1611 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
Year 1, n=1610, 1623, 1611
|
29 events
|
27 events
|
40 events
|
|
Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
Year 2, n=1457, 1484, 1464
|
14 events
|
22 events
|
62 events
|
|
Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
Year 3, n=1347, 1365, 1307
|
15 events
|
16 events
|
44 events
|
|
Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
Year 4, n=1274, 1277, 1176
|
9 events
|
19 events
|
45 events
|
PRIMARY outcome
Timeframe: Baseline (Day 1) through Year 4Population: ITT Population
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1610 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1623 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1611 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Participants With AUR or BPH-related Surgery
AUR
|
35 participants
|
44 participants
|
109 participants
|
|
Number of Participants With AUR or BPH-related Surgery
BPH-related surgery
|
32 participants
|
40 participants
|
82 participants
|
SECONDARY outcome
Timeframe: Years 1, 2, 3, and 4Population: ITT Population. As the study progressed, participants dropped out of the study.
The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1610 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1623 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1611 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4
Year 1, n=1610, 1623, 1611
|
126 events
|
184 events
|
171 events
|
|
Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4
Year 2, n= 1264, 1240, 1262
|
31 events
|
54 events
|
78 events
|
|
Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4
Year 3, n=1135, 1082, 1048
|
30 events
|
29 events
|
67 events
|
|
Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4
Year 4, n= 1047, 959, 880
|
16 events
|
22 events
|
31 events
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Year 4Population: ITT Population
The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1610 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1623 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1611 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
The Number of Participants With Each of the Five Components of BPH Clinical Progression
Symptom deterioration
|
132 participants
|
203 participants
|
221 participants
|
|
The Number of Participants With Each of the Five Components of BPH Clinical Progression
BPH-related AUR
|
22 participants
|
31 participants
|
64 participants
|
|
The Number of Participants With Each of the Five Components of BPH Clinical Progression
BPH-related incontinence
|
46 participants
|
49 participants
|
56 participants
|
|
The Number of Participants With Each of the Five Components of BPH Clinical Progression
Recurrent BPH-related UTI
|
2 participants
|
5 participants
|
3 participants
|
|
The Number of Participants With Each of the Five Components of BPH Clinical Progression
BPH-related renal insufficiency
|
1 participants
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)Population: Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.
The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1610 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1623 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1611 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Events of Symptom Deterioration at the Indicated Time Periods
Year 1, n=1610, 1623, 1611
|
91 events
|
138 events
|
119 events
|
|
Number of Events of Symptom Deterioration at the Indicated Time Periods
Year 2, n=1286, 1278, 1296
|
23 events
|
38 events
|
49 events
|
|
Number of Events of Symptom Deterioration at the Indicated Time Periods
Year 3, n=1158, 1132, 1088
|
14 events
|
23 events
|
42 events
|
|
Number of Events of Symptom Deterioration at the Indicated Time Periods
Year 4, n=1083, 1001, 926
|
11 events
|
13 events
|
19 events
|
SECONDARY outcome
Timeframe: Baseline (Day 1) through Year 4Population: ITT Population
A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1610 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1623 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1611 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria
Overall crude rate
|
53 participants
|
70 participants
|
81 participants
|
|
Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria
Non-BPH-related Crude Rate
|
15 participants
|
28 participants
|
25 participants
|
|
Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria
BPH-Related Crude Rate
|
40 participants
|
45 participants
|
56 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) through Year 4Population: ITT Population
A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1610 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1623 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1611 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Participants With an Event of Post-baseline BPH-related Hematospermia
Overall Crude Rate
|
18 participants
|
19 participants
|
20 participants
|
|
Number of Participants With an Event of Post-baseline BPH-related Hematospermia
Non-BPH-related Crude Rate
|
2 participants
|
3 participants
|
9 participants
|
|
Number of Participants With an Event of Post-baseline BPH-related Hematospermia
BPH-related Crude Rate
|
17 participants
|
17 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study.
The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1575 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1592 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1582 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48
Month 12
|
-5.6 points on a scale
Standard Error 0.15
|
-4.2 points on a scale
Standard Error 0.15
|
-4.5 points on a scale
Standard Error 0.15
|
|
Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48
Month 24
|
-6.2 points on a scale
Standard Error 0.15
|
-4.9 points on a scale
Standard Error 0.15
|
-4.3 points on a scale
Standard Error 0.15
|
|
Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48
Month 36
|
-6.3 points on a scale
Standard Error 0.16
|
-5.2 points on a scale
Standard Error 0.16
|
-4.0 points on a scale
Standard Error 0.16
|
|
Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48
Month 48
|
-6.3 points on a scale
Standard Error 0.16
|
-5.3 points on a scale
Standard Error 0.16
|
-3.8 points on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Also, assessments with voided volumes \<125 ml were not included in the analysis.
Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1495 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1505 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1523 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48
Month 12, n=1477, 1482, 1510
|
2.0 milliliters (mL)/second (sec)
Standard Error 0.12
|
1.5 milliliters (mL)/second (sec)
Standard Error 0.12
|
0.9 milliliters (mL)/second (sec)
Standard Error 0.12
|
|
Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48
Month 24, n= 1492, 1501, 1519
|
2.4 milliliters (mL)/second (sec)
Standard Error 0.12
|
1.9 milliliters (mL)/second (sec)
Standard Error 0.12
|
0.9 milliliters (mL)/second (sec)
Standard Error 0.12
|
|
Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48
Month 36, n= 1495, 1504, 1521
|
2.6 milliliters (mL)/second (sec)
Standard Error 0.12
|
1.9 milliliters (mL)/second (sec)
Standard Error 0.12
|
0.6 milliliters (mL)/second (sec)
Standard Error 0.12
|
|
Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48
Month 48, n= 1495, 1505, 1523
|
2.4 milliliters (mL)/second (sec)
Standard Error 0.13
|
2.0 milliliters (mL)/second (sec)
Standard Error 0.13
|
0.7 milliliters (mL)/second (sec)
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Also, prostate measurements were either not performed or missing for some participants at various timepoints.
Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = \[(post-baseline - baseline)/baseline value\] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1430 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1455 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1468 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48
Month 12, n=1411, 1442, 1451
|
-24.1 percent change
Standard Error 0.60
|
-25.2 percent change
Standard Error 0.59
|
-1.5 percent change
Standard Error 0.77
|
|
Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48
Month 24, n= 1427, 1451, 1465
|
-26.9 percent change
Standard Error 0.62
|
-28.0 percent change
Standard Error 0.61
|
0.0 percent change
Standard Error 0.84
|
|
Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48
Month 36, n= 1430, 1455, 1468
|
-27.6 percent change
Standard Error 0.68
|
-28.8 percent change
Standard Error 0.66
|
1.6 percent change
Standard Error 0.94
|
|
Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48
Month 48, n= 1430, 1455, 1468
|
-27.3 percent change
Standard Error 0.66
|
-28.0 percent change
Standard Error 0.65
|
4.6 percent change
Standard Error 0.94
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Transition zone measurements were only done on a subset of participants at sites with experience in measuring the transition zone of the prostate. Also, transition zone measurements were either not performed or missing for some participants at various timepoints.
Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = \[(post-BL - BL)/BL value\] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=155 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=164 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=163 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48
Month 12, n= 150, 159, 160
|
-17.2 percent change
Standard Error 3.29
|
-15.6 percent change
Standard Error 3.39
|
5.6 percent change
Standard Error 4.09
|
|
Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48
Month 24, n= 153, 164, 160
|
-23.4 percent change
Standard Error 5.63
|
-22.8 percent change
Standard Error 5.86
|
8.7 percent change
Standard Error 8.22
|
|
Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48
Month 36, n= 155, 164, 162
|
-20.9 percent change
Standard Error 3.97
|
-26.7 percent change
Standard Error 3.90
|
14.7 percent change
Standard Error 5.89
|
|
Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48
Month 48, n= 155, 164, 163
|
-17.9 percent change
Standard Error 4.45
|
-26.5 percent change
Standard Error 4.21
|
18.2 percent change
Standard Error 6.54
|
SECONDARY outcome
Timeframe: Every 3 months from Month 3 to Month 48Population: ITT Population. As the study progressed, participants dropped out of the study.
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit?" If the answer to the question was "yes," the number of visits was recorded.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1550 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1581 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1565 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 3, n=1550, 1581, 1565
|
8 visits
|
6 visits
|
7 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 6, n=1479, 1517, 1514
|
2 visits
|
4 visits
|
3 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 9, n=1439, 1465, 1477
|
4 visits
|
3 visits
|
8 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 12, n=1400, 1431, 1434
|
3 visits
|
3 visits
|
9 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 15, n=1343, 1386, 1380
|
3 visits
|
6 visits
|
6 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 18, n=1318, 1350, 1328
|
3 visits
|
4 visits
|
10 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 21, n=1281, 1326, 1287
|
3 visits
|
3 visits
|
9 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 24, n=1263, 1293, 1244
|
2 visits
|
2 visits
|
7 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 27, n=1233, 1262, 1206
|
1 visits
|
6 visits
|
7 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 30, n=1222, 1221, 1166
|
3 visits
|
2 visits
|
8 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 33, n=1202, 1199, 1128
|
3 visits
|
4 visits
|
5 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 36, n=1187, 1174, 1095
|
2 visits
|
1 visits
|
5 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 39, n=1160, 1144, 1055
|
2 visits
|
2 visits
|
5 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 42, n=1149, 1126, 1035
|
3 visits
|
2 visits
|
8 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 45, n=1129, 1110, 1009
|
1 visits
|
2 visits
|
4 visits
|
|
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
Month 48, n=1113, 1093, 990
|
1 visits
|
2 visits
|
2 visits
|
SECONDARY outcome
Timeframe: Every 3 months from Month 3 to Month 48Population: ITT Population. As the study progressed, participants dropped out of the study.
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?". If the answer to the question was "yes," the number of Yes responses was recorded.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1550 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1581 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1564 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 3, n=1550, 1581, 1564
|
31 yes responses
|
32 yes responses
|
29 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 6, n=1479, 1516, 1513
|
21 yes responses
|
26 yes responses
|
26 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 9, n=1439, 1465, 1477
|
18 yes responses
|
14 yes responses
|
18 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 12, n=1400, 1431, 1434
|
8 yes responses
|
13 yes responses
|
9 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 15, n=1343, 1386, 1380
|
9 yes responses
|
15 yes responses
|
12 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 18, n=1318, 1350, 1328
|
17 yes responses
|
13 yes responses
|
19 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 21, n=1281, 1326, 1287
|
10 yes responses
|
15 yes responses
|
17 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 24, n=1263, 1293, 1244
|
5 yes responses
|
9 yes responses
|
8 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 27, n=1233, 1262, 1206
|
9 yes responses
|
11 yes responses
|
8 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 30, n=1222, 1221, 1166
|
7 yes responses
|
9 yes responses
|
9 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 33, n=1202, 1199, 1128
|
9 yes responses
|
10 yes responses
|
11 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 36, n=1187, 1174, 1095
|
5 yes responses
|
4 yes responses
|
5 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 39, n=1160, 1144, 1055
|
7 yes responses
|
9 yes responses
|
6 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 42, n=1149, 1126, 1035
|
6 yes responses
|
8 yes responses
|
8 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 45, n=1129, 1110, 1009
|
7 yes responses
|
8 yes responses
|
5 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
Month 48, n=1113, 1093, 990
|
2 yes responses
|
9 yes responses
|
5 yes responses
|
SECONDARY outcome
Timeframe: Every 3 months from Month 3 to Month 48Population: ITT Population. As the study progressed, participants dropped out of the study.
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of visits was recorded.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1550 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1581 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1564 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 3, n=1550, 1581, 1564
|
0 visits
|
3 visits
|
3 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 6, n=1479, 1517, 1514
|
2 visits
|
1 visits
|
2 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 9, n=1439, 1465, 1477
|
2 visits
|
2 visits
|
3 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 12, n=1400, 1431, 1434
|
1 visits
|
2 visits
|
7 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 15, n=1343, 1386, 1380
|
2 visits
|
5 visits
|
7 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 18, n=1318, 1350, 1328
|
4 visits
|
0 visits
|
4 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 21, n=1281, 1326, 1287
|
1 visits
|
0 visits
|
3 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 24, n=1263, 1293, 1244
|
2 visits
|
0 visits
|
3 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 27, n=1233, 1262, 1206
|
3 visits
|
3 visits
|
4 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 30, n=1222, 1221, 1165
|
0 visits
|
1 visits
|
1 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 33, n=1202, 1199, 1128
|
0 visits
|
1 visits
|
5 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 36, n=1187, 1174, 1095
|
2 visits
|
2 visits
|
1 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 39, n=1160, 1144, 1055
|
1 visits
|
3 visits
|
2 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 42, n=1149, 1126, 1035
|
1 visits
|
2 visits
|
5 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 45, n=1129, 1110, 1009
|
0 visits
|
3 visits
|
2 visits
|
|
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
Month 48, n=1113, 1093, 990
|
0 visits
|
2 visits
|
1 visits
|
SECONDARY outcome
Timeframe: Every 3 months from Month 3 to Month 48Population: ITT Population. As study progressed, participants dropped out of study.
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of Yes responses was recorded.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1550 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1581 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1564 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 3, n=1550, 1581, 1564
|
16 yes responses
|
34 yes responses
|
28 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 6, n=1479, 1516, 1513
|
20 yes responses
|
23 yes responses
|
16 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 9, n=1438, 1465, 1477
|
12 yes responses
|
10 yes responses
|
17 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 12, n=1400, 1431, 1434
|
5 yes responses
|
10 yes responses
|
6 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 15, n=1343, 1386, 1380
|
9 yes responses
|
9 yes responses
|
9 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 18, n=1318, 1350, 1328
|
13 yes responses
|
12 yes responses
|
10 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 21, n=1281, 1326, 1287
|
10 yes responses
|
9 yes responses
|
8 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 24, n=1263, 1293, 1244
|
4 yes responses
|
7 yes responses
|
3 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 27, n=1233, 1262, 1206
|
9 yes responses
|
9 yes responses
|
5 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 30, n=1222, 1221, 1166
|
7 yes responses
|
9 yes responses
|
4 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 33, n=1202, 1199, 1128
|
5 yes responses
|
7 yes responses
|
8 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 36, n=1187, 1174, 1095
|
3 yes responses
|
5 yes responses
|
2 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 39, n=1160, 1144, 1055
|
7 yes responses
|
8 yes responses
|
5 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 42, n=1149, 1126, 1034
|
9 yes responses
|
8 yes responses
|
2 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 45, n=1129, 1110, 1009
|
6 yes responses
|
8 yes responses
|
5 yes responses
|
|
Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
Month 48, n=1113, 1093, 990
|
1 yes responses
|
3 yes responses
|
1 yes responses
|
SECONDARY outcome
Timeframe: Every 3 months from Month 3 to Month 48Population: ITT Population. As study progressed, participants dropped out of the study.
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?". If the answer to the question was "yes," the number of visits was recorded.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1550 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1581 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1564 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 30, n=1222, 1221, 1166
|
7 visits
|
8 visits
|
10 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 33, n=1202, 1199, 1128
|
4 visits
|
5 visits
|
10 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 3, n=1550, 1581, 1564
|
23 visits
|
25 visits
|
26 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 36, n=1187, 1174, 1095
|
5 visits
|
4 visits
|
7 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 39, n=1160, 1144, 1055
|
6 visits
|
13 visits
|
19 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 42, n=1149, 1126, 1035
|
4 visits
|
8 visits
|
12 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 6, n=1479, 1517, 1514
|
23 visits
|
34 visits
|
22 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 45, n=1129, 1110, 1009
|
3 visits
|
5 visits
|
6 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 48, n=1113, 1093, 990
|
1 visits
|
6 visits
|
5 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 9, n=1439, 1465, 1477
|
16 visits
|
35 visits
|
22 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 12, n=1400, 1431, 1434
|
30 visits
|
29 visits
|
34 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 15, n=1343, 1386, 1380
|
24 visits
|
22 visits
|
27 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 18, n=1318, 1350, 1328
|
21 visits
|
25 visits
|
26 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 21, n=1281, 1326, 1287
|
18 visits
|
21 visits
|
14 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 24, n=1263, 1293, 1244
|
10 visits
|
19 visits
|
21 visits
|
|
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 27, n=1233, 1262, 1206
|
15 visits
|
11 visits
|
14 visits
|
SECONDARY outcome
Timeframe: Every 3 months from Month 3 to Month 48Population: ITT Population. As study progressed, participants dropped out the study.
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?". If the answer to the question was "yes," the number of visits was recorded.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1550 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1581 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1564 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 3, n=1550, 1581, 1564
|
27 visits
|
27 visits
|
30 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 6, n=1479, 1516, 1514
|
23 visits
|
29 visits
|
33 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 9, n=1439, 1465, 1477
|
12 visits
|
27 visits
|
26 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 12, n=1400, 1431, 1434
|
30 visits
|
28 visits
|
29 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 15, n=1343, 1386, 1381
|
19 visits
|
28 visits
|
32 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 18, n=1318, 1350, 1328
|
23 visits
|
21 visits
|
34 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 21, n=1281, 1326, 1287
|
20 visits
|
27 visits
|
26 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 24, n=1263, 1293, 1244
|
29 visits
|
23 visits
|
26 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 27, n=1233, 1262, 1206
|
13 visits
|
12 visits
|
16 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 30, n=1222, 1221, 1166
|
10 visits
|
16 visits
|
10 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 33, n=1202, 1199, 1128
|
6 visits
|
13 visits
|
20 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 36, n=1187, 1174, 1095
|
8 visits
|
12 visits
|
18 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 39, n=1160, 1144, 1055
|
12 visits
|
10 visits
|
18 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 42, n=1149, 1126, 1035
|
15 visits
|
9 visits
|
15 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 45, n=1129, 1110, 1009
|
5 visits
|
7 visits
|
8 visits
|
|
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
Month 48, n=1113, 1093, 990
|
7 visits
|
4 visits
|
8 visits
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study.
The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1574 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1593 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1582 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48
Month 12
|
-1.9 points on a scale
Standard Error 0.06
|
-1.5 points on a scale
Standard Error 0.06
|
-1.6 points on a scale
Standard Error 0.06
|
|
Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48
Month 24
|
-2.1 points on a scale
Standard Error 0.07
|
-1.7 points on a scale
Standard Error 0.07
|
-1.5 points on a scale
Standard Error 0.07
|
|
Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48
Month 36
|
-2.2 points on a scale
Standard Error 0.07
|
-1.8 points on a scale
Standard Error 0.07
|
-1.3 points on a scale
Standard Error 0.07
|
|
Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48
Month 48
|
-2.2 points on a scale
Standard Error 0.07
|
-1.8 points on a scale
Standard Error 0.07
|
-1.2 points on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, 48Population: ITT Population. As the study progressed, participants dropped out of the study.
The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = \[(post-baseline - baseline)/baseline value\] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1575 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1592 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1583 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48
Month 12
|
-1.2 points on a scale
Standard Error 0.03
|
-1.0 points on a scale
Standard Error 0.03
|
-1.0 points on a scale
Standard Error 0.03
|
|
Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48
Month 24
|
-1.4 points on a scale
Standard Error 0.03
|
-1.1 points on a scale
Standard Error 0.03
|
-1.1 points on a scale
Standard Error 0.03
|
|
Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48
Month 36
|
-1.5 points on a scale
Standard Error 0.03
|
-1.2 points on a scale
Standard Error 0.03
|
-1.1 points on a scale
Standard Error 0.03
|
|
Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48
Month 48
|
-1.5 points on a scale
Standard Error 0.03
|
-1.3 points on a scale
Standard Error 0.03
|
-1.1 points on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has control of your urinary problems changed?".
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1685 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1600 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1586 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
Baseline (BL), Any Improvement, n=1585, 1600, 1586
|
696 participants
|
656 participants
|
706 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
BL, No Change/Any Worsening, n=1585, 1600, 1586
|
889 participants
|
944 participants
|
880 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
Month (M) 12, Any Improvement, n=1576, 1593, 1581
|
1281 participants
|
1171 participants
|
1218 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
M12, No Change/Any Worsening, n=1576, 1593, 1581
|
295 participants
|
422 participants
|
363 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
M24, Any Improvement, n=1576, 1593, 1581
|
1273 participants
|
1200 participants
|
1195 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
M24, No Change/Any Worsening, n=1576, 1593, 1581
|
303 participants
|
393 participants
|
386 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
M36, Any Improvement, n=1576, 1593, 1581
|
1268 participants
|
1203 participants
|
1152 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
M36, No Change/Any Worsening, n=1576, 1593, 1581
|
308 participants
|
390 participants
|
429 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
M48, Any Improvement, n=1576, 1593, 1581
|
1278 participants
|
1212 participants
|
1138 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
M48, No Change/Any Worsening, n=1576, 1593, 1581
|
298 participants
|
381 participants
|
443 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on control of your urinary problems?" Satisfact., satisfaction.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1587 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1600 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1583 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
Baseline (BL), Any Satisfact., n=1587, 1600, 1583
|
707 participants
|
652 participants
|
686 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
BL, Neutral/Any Dissatisfact., n=1587, 1600, 1583
|
880 participants
|
948 participants
|
897 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
Month (M) 12, Any Satisfact., n=1576, 1593, 1581
|
1224 participants
|
1127 participants
|
1178 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581
|
352 participants
|
466 participants
|
403 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
M24, Any Satisfact., n=1576, 1593, 1581
|
1261 participants
|
1166 participants
|
1150 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581
|
315 participants
|
427 participants
|
431 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
M36, Any Satisfact., n=1576, 1593, 1581
|
1260 participants
|
1167 participants
|
1120 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581
|
316 participants
|
426 participants
|
461 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
M48, Any Satisfact., n=1576, 1593, 1581
|
1267 participants
|
1172 participants
|
1088 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581
|
309 participants
|
421 participants
|
493 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has the strength of your urinary stream changed?".
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1585 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1601 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1585 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
Baseline (BL), Any Improvement, n=1585, 1601, 1585
|
629 participants
|
602 participants
|
615 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
BL, No Change/Any Worsening, n=1585, 1601, 1585
|
956 participants
|
999 participants
|
970 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
Month (M) 12, Any Improvement, n=1576, 1593, 158
|
1181 participants
|
1044 participants
|
1105 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
M12, No Change/Any Worsening, n=1576, 1593, 1581
|
395 participants
|
549 participants
|
476 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
M24, Any Improvement, n=1576, 1593, 1581
|
1215 participants
|
1070 participants
|
1057 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
M24, No Change/Any Worsening, n=1576, 1593, 1581
|
361 participants
|
523 participants
|
524 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
M36, Any Improvement, n=1576, 1593, 1581
|
1206 participants
|
1071 participants
|
1023 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
M36, No Change/Any Worsening, n=1576, 1593, 1581
|
370 participants
|
522 participants
|
558 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
M48, Any Improvement, n=1576, 1593, 1581
|
1202 participants
|
1086 participants
|
1008 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
M48, No Change/Any Worsening, n=1576, 1593, 1581
|
374 participants
|
507 participants
|
573 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on the strength of your urinary stream?". Satisfact., satisfaction.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1583 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1601 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1582 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
Baseline (BL), Any Satisfact., n=1583,1601,1582
|
632 participants
|
586 participants
|
613 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
BL, Neutral/Any Dissatisfact., n=1583,1601,1582
|
951 participants
|
1015 participants
|
969 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
Month (M) 12, Any Satisfact., n=1576, 1593, 1581
|
1154 participants
|
1037 participants
|
1097 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581
|
422 participants
|
556 participants
|
484 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
M24, Any Satisfact., n=1576, 1593, 1581
|
1203 participants
|
1072 participants
|
1051 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581
|
373 participants
|
521 participants
|
530 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
M36, Any Satisfact., n=1576, 1593, 1581
|
1201 participants
|
1075 participants
|
1039 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581
|
375 participants
|
518 participants
|
542 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
M48, Any Satisfact., n=1576, 1593, 1581
|
1208 participants
|
1089 participants
|
1022 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581
|
368 participants
|
504 participants
|
559 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has your pain prior to urinating changed?".
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=869 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=901 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=849 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
Baseline (BL), Any Improvement, n=869, 901, 849
|
337 participants
|
331 participants
|
332 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
BL, No Change/Any Worsening, n=869, 901, 849
|
532 participants
|
570 participants
|
517 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
Month (M) 12, Any Improvement, n=769, 817, 771
|
556 participants
|
526 participants
|
527 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
M12, No Change/Any Worsening, n=769, 817, 771
|
213 participants
|
291 participants
|
244 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
M24, Any Improvement, n=720, 780, 771
|
537 participants
|
526 participants
|
535 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
M24, No Change/Any Worsening, n=720, 780, 771
|
183 participants
|
254 participants
|
236 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
M36, Any Improvement, n=714, 753, 748
|
540 participants
|
514 participants
|
496 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
M36, No Change/Any Worsening, n=714, 753, 748
|
174 participants
|
239 participants
|
252 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
M48, Any Improvement, n=709, 756, 751
|
531 participants
|
510 participants
|
489 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
M48, No Change/Any Worsening, n=709, 756, 751
|
178 participants
|
246 participants
|
262 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain prior to urinating?". Satisfact., satisfaction.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1135 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1223 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1161 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
Baseline (BL), Any Satisfact., n=908, 932, 889
|
375 participants
|
351 participants
|
351 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
BL, Neutral/Any Dissatisfact., n=908, 932, 889
|
533 participants
|
581 participants
|
538 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
Month (M) 12, Any Satisfact., n=1022, 1088, 1019
|
712 participants
|
672 participants
|
681 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
M12, Neutral/Any Dissatisfact., n=1022, 1088, 1019
|
310 participants
|
416 participants
|
338 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
M24, Any Satisfact., n=1077, 1151, 1085
|
764 participants
|
740 participants
|
708 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
M24, Neutral/Any Dissatisfact., n=1077, 1151, 1085
|
313 participants
|
411 participants
|
377 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
M36, Any Satisfact., n=1115, 1200, 1135
|
799 participants
|
785 participants
|
736 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
M36, Neutral/Any Dissatisfact., n=1115, 1200, 1135
|
316 participants
|
415 participants
|
399 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
M48, Any Satisfact., n=1135, 1223, 1161
|
810 participants
|
792 participants
|
739 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
M48, Neutral/Any Dissatisfact., n=1135, 1223, 1161
|
325 participants
|
431 participants
|
422 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has your pain during urination changed?".
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=852 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=889 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=822 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
Baseline (BL), Any Improvement, n=852, 889, 822
|
321 participants
|
314 participants
|
319 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
BL, No Change/Any Worsening, n=852, 889, 822
|
531 participants
|
575 participants
|
503 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
Month (M) 12, Any Improvement, n=760, 781, 755
|
550 participants
|
500 participants
|
529 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
M12, No Change/Any Worsening, n=760, 781, 755
|
210 participants
|
281 participants
|
226 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
M24, Any Improvement, n=706, 760, 747
|
532 participants
|
508 participants
|
519 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
M24, No Change/Any Worsening, n=706, 760, 747
|
174 participants
|
252 participants
|
228 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
M36, Any Improvement, n=704, 741, 733
|
529 participants
|
504 participants
|
491 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
M36, No Change/Any Worsening, n=704, 741, 733
|
175 participants
|
237 participants
|
242 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
M48, No Change/Any Worsening, n=702, 739, 740
|
175 participants
|
252 participants
|
257 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
M48, Any Improvement, n=702, 739, 740
|
527 participants
|
487 participants
|
483 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain during urination?". Satisfact., satisfaction.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1146 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1224 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1160 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
Baseline (BL), Any Satisfact., n=890, 925, 851
|
354 participants
|
348 participants
|
333 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
BL, Neutral/Any Dissatisfact., n=890, 925, 851
|
536 participants
|
577 participants
|
518 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
Month (M) 12, Any Satisfact., n=1022, 1088, 1011
|
712 participants
|
655 participants
|
678 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
M12, Neutral/Any Dissatisfact., n=1022, 1088, 1011
|
310 participants
|
433 participants
|
333 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
M24, Any Satisfact., n=1077, 1155, 1079
|
763 participants
|
730 participants
|
708 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
M24, Neutral/Any Dissatisfact., n=1077, 1155, 1079
|
314 participants
|
425 participants
|
371 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
M36, Any Satisfact., n=1121, 1206, 1131
|
807 participants
|
784 participants
|
724 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
M36, Neutral/Any Dissatisfact., n=1121, 1206, 1131
|
314 participants
|
422 participants
|
407 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
M48, Any Satsifact., n=1146,1224,1160
|
827 participants
|
785 participants
|
729 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
M48, Neutral/Any Dissatisfact., n=1146, 1224, 1160
|
319 participants
|
439 participants
|
431 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?".
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1575 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1593 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1580 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
Baseline (BL), Any Improvement, n=1574, 1599, 1575
|
509 participants
|
481 participants
|
494 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
BL, No Change/Any Worsening, n=1574, 1599, 1575
|
1065 participants
|
1118 participants
|
1081 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
Month (M) 12, Any Improvement, n=1575, 1593, 1580
|
1124 participants
|
1027 participants
|
1084 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
M12, No Change/Any Worsening, n=1575, 1593, 1580
|
451 participants
|
566 participants
|
496 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
M24, Any Improvement, n=1575, 1593, 1580
|
1146 participants
|
1053 participants
|
1049 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
M24, No Change/Any Worsening, n=1575, 1593, 1580
|
429 participants
|
540 participants
|
531 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
M36, Any Improvement, n=1575, 1593, 1580
|
1575 participants
|
1593 participants
|
1580 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
M36, No Change/Any Worsening, n=1575, 1593, 1580
|
412 participants
|
529 participants
|
553 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
M48, Any Improvement, n=1575, 1593, 1580
|
1148 participants
|
1063 participants
|
1008 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
M48, No Change/Any Worsening, n=1575, 1593, 1580
|
427 participants
|
530 participants
|
572 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?". Satisfact., satisfaction.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1575 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1593 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1580 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
Baseline (BL), Any Satisfact., n=1574, 1600, 1576
|
611 participants
|
565 participants
|
584 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
BL, Neutral /Any Dissatisfact., n=1574, 1600, 1576
|
963 participants
|
1035 participants
|
992 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
Month (M) 12, Any Satisfact., n=1575, 1593, 1580
|
1176 participants
|
1073 participants
|
1114 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
M12, Neutral/Any Dissatisfact., n=1575, 1593, 1580
|
399 participants
|
520 participants
|
466 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
M24, Any Satisfact., n=1575, 1593, 1580
|
1205 participants
|
1116 participants
|
1088 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
M24, Neutral/Any Dissatisfact., n=1575, 1593, 1580
|
370 participants
|
477 participants
|
492 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
M36, Any Satisfact., n=1575, 1593, 1580
|
1210 participants
|
1098 participants
|
1074 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
M36, Neutral/Any Dissatisfact., n=1575, 1593, 1580
|
365 participants
|
495 participants
|
506 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
M48, Any Satisfact., n=1575, 1593, 1580
|
1213 participants
|
1123 participants
|
1043 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
M48, Neutral/Any Dissatisfact., n=1575, 1593, 1580
|
362 participants
|
470 participants
|
537 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Overall, how satisfied are you with the study medication and it's effect on your urinary problems?". Satisfact., satisfaction.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1574 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1592 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1581 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
Baseline (BL), Any Satisfact., n=1573, 1598, 1574
|
717 participants
|
683 participants
|
699 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
BL, Neutral/Any Dissatisfact., n=1573, 1598, 1574
|
856 participants
|
915 participants
|
875 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
Month (M) 12, Any Satisfact., n=1574, 1592, 1581
|
150 participants
|
1159 participants
|
1202 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
M12, Neutral/Any Dissatisfact., n=1574, 1592, 1581
|
324 participants
|
433 participants
|
379 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
M24, Any Satisfact., n=1574, 1592, 1581
|
1279 participants
|
1188 participants
|
1163 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
M24, Neutral/Any Dissatisfact., n=1574, 1592, 1581
|
295 participants
|
404 participants
|
418 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
M36, Any Satisfact., n=1574, 1592, 1581
|
1270 participants
|
1188 participants
|
1119 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
M36, Neutral/Any Dissatisfact., n=1574, 1592, 1581
|
304 participants
|
404 participants
|
462 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
M48, Any Satifact., n=1574, 1592, 1581
|
1262 participants
|
1182 participants
|
1097 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
M48, Neutral/Any Dissatisfact., n=1574, 1592, 1581
|
312 participants
|
410 participants
|
484 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 12, 24, 36, and 48Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Would you ask your doctor for the medication you received in this study?".
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=1574 Participants
Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
|
Dutasteride 0.5 mg
n=1592 Participants
Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
|
Tamsulosin 0.4 mg
n=1581 Participants
Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
|
|---|---|---|---|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Baseline, Yes, n=1560, 1579, 1562
|
587 participants
|
557 participants
|
582 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Baseline, No/Not Sure, n=1560, 1579, 1562
|
973 participants
|
1022 participants
|
980 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Month 12, Yes, n=1574, 1592, 1581
|
972 participants
|
920 participants
|
970 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Month 12, No/Not Sure, n=1574, 1592, 1581
|
602 participants
|
671 participants
|
611 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Month 24, Yes, n=1574, 1592, 1581
|
1027 participants
|
955 participants
|
952 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Month 24, No/Not Sure, n=1574, 1592, 1581
|
547 participants
|
636 participants
|
629 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Month 36, Yes, n=1574, 1592, 1581
|
1031 participants
|
956 participants
|
915 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Month 36, No/Not Sure, n=1574, 1592, 1581
|
543 participants
|
636 participants
|
666 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Month 48, Yes, n=1574, 1592, 1581
|
1003 participants
|
918 participants
|
874 participants
|
|
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
Month 48, No/Not Sure, n=1574, 1592, 1581
|
571 participants
|
674 participants
|
707 participants
|
Adverse Events
Combination
Serious events: 303 serious events
Other events: 618 other events
Deaths: 0 deaths
Dutasteride 0.5 mg
Serious events: 339 serious events
Other events: 586 other events
Deaths: 0 deaths
Tamsulosin 0.4 mg
Serious events: 348 serious events
Other events: 590 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination
n=1610 participants at risk
|
Dutasteride 0.5 mg
n=1623 participants at risk
|
Tamsulosin 0.4 mg
n=1611 participants at risk
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign colonic neoplasm
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Endocrine disorders
Goitre
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Pericardial effusion
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Myocardial infarction
|
0.99%
16/1610
|
1.5%
25/1623
|
1.2%
20/1611
|
|
Cardiac disorders
Coronary artery disease
|
0.87%
14/1610
|
0.86%
14/1623
|
0.93%
15/1611
|
|
Cardiac disorders
Angina pectoris
|
0.87%
14/1610
|
0.86%
14/1623
|
0.93%
15/1611
|
|
Cardiac disorders
Atrial fibrillation
|
0.68%
11/1610
|
0.43%
7/1623
|
0.56%
9/1611
|
|
Cardiac disorders
Acute myocardial infarction
|
0.43%
7/1610
|
0.06%
1/1623
|
0.19%
3/1611
|
|
Cardiac disorders
Cardiac failure
|
0.31%
5/1610
|
0.06%
1/1623
|
0.31%
5/1611
|
|
Cardiac disorders
Coronary artery stenosis
|
0.25%
4/1610
|
0.31%
5/1623
|
0.12%
2/1611
|
|
Cardiac disorders
Myocardial ischaemia
|
0.19%
3/1610
|
0.18%
3/1623
|
0.19%
3/1611
|
|
Cardiac disorders
Angina unstable
|
0.06%
1/1610
|
0.18%
3/1623
|
0.25%
4/1611
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.06%
1/1610
|
0.12%
2/1623
|
0.25%
4/1611
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
3/1610
|
0.18%
3/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Bradycardia
|
0.19%
3/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Cardiac failure congestive
|
0.25%
4/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Coronary artery occlusion
|
0.06%
1/1610
|
0.18%
3/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Sick sinus syndrome
|
0.06%
1/1610
|
0.25%
4/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/1610
|
0.18%
3/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Atrial flutter
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Cardiac arrest
|
0.12%
2/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Mitral valve incompetence
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.12%
2/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Ventricular tachycardia
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
AV dissociation
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Cardiac asthma
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Cardiac failure chronic
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Coronary artery aneurysm
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Cardiovascular deconditioning
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.3%
21/1610
|
1.0%
17/1623
|
1.6%
25/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.37%
6/1610
|
0.55%
9/1623
|
0.31%
5/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.37%
6/1610
|
0.37%
6/1623
|
0.25%
4/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.19%
3/1610
|
0.12%
2/1623
|
0.31%
5/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.06%
1/1610
|
0.12%
2/1623
|
0.12%
2/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.06%
1/1610
|
0.06%
1/1623
|
0.19%
3/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.12%
2/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.25%
4/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.06%
1/1610
|
0.18%
3/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.06%
1/1610
|
0.12%
2/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/1610
|
0.18%
3/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.19%
3/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.06%
1/1610
|
0.18%
3/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/1610
|
0.18%
3/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.06%
1/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/1610
|
0.00%
0/1623
|
0.19%
3/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/1610
|
0.00%
0/1623
|
0.19%
3/1611
|
|
Cardiac disorders
Acute myeloid leukaemia
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neolasm
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant palate neoplasm
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retinal melanoma
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tracheal cancer
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary bladder adenoma
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract neoplasm
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage II
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage III
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Cerebrovascular accident
|
0.68%
11/1610
|
0.92%
15/1623
|
0.50%
8/1611
|
|
Nervous system disorders
Transient ischaemic attack
|
0.31%
5/1610
|
0.31%
5/1623
|
0.25%
4/1611
|
|
Nervous system disorders
Syncope
|
0.37%
6/1610
|
0.06%
1/1623
|
0.19%
3/1611
|
|
Nervous system disorders
Cerebral infarction
|
0.06%
1/1610
|
0.25%
4/1623
|
0.19%
3/1611
|
|
Nervous system disorders
Ischaemic stroke
|
0.06%
1/1610
|
0.00%
0/1623
|
0.25%
4/1611
|
|
Nervous system disorders
Cerebral ischaemia
|
0.19%
3/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Dizziness
|
0.06%
1/1610
|
0.12%
2/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Carotid artery stenosis
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Nervous system disorders
Convulsion
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Grand mal convulsions
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Loss of consciousness
|
0.12%
2/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain stem ischaemia
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Neuritis
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Sciatica
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Senile dementia
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Nervous system disorders
Carotid artery occlusion
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Radicular pain
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Nerve root compression
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.25%
4/1610
|
1.0%
17/1623
|
0.68%
11/1611
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
5/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Gastrointestinal disorders
Colonic polyp
|
0.06%
1/1610
|
0.25%
4/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.12%
2/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Pancreatitis
|
0.12%
2/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.06%
1/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.06%
1/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1610
|
0.12%
2/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.06%
1/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Gastritis
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Rectal polyp
|
0.12%
2/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Volvulus
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Pharyngoesophageal diverticulum
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Appendix disorder
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Anal prolapse
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Pneumonia
|
0.81%
13/1610
|
0.62%
10/1623
|
0.37%
6/1611
|
|
Infections and infestations
Urniary tract infection
|
0.19%
3/1610
|
0.06%
1/1623
|
0.19%
3/1611
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Cellulitis
|
0.19%
3/1610
|
0.18%
3/1623
|
0.00%
0/1611
|
|
Infections and infestations
Sepsis
|
0.06%
1/1610
|
0.12%
2/1623
|
0.19%
3/1611
|
|
Infections and infestations
Bronchitis
|
0.12%
2/1610
|
0.00%
0/1623
|
0.19%
3/1611
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1610
|
0.18%
3/1623
|
0.12%
2/1611
|
|
Infections and infestations
Lobar pneumonia
|
0.06%
1/1610
|
0.12%
2/1623
|
0.06%
1/1611
|
|
Infections and infestations
Urosepis
|
0.06%
1/1610
|
0.00%
0/1623
|
0.19%
3/1611
|
|
Infections and infestations
Bronchopneumonia
|
0.12%
2/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Infections and infestations
Septic shock
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Infections and infestations
Viral infection
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Infections and infestations
Device related infection
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Abcess intestinal
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Carbuncle
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Cystitis
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Infections and infestations
Dengue fever
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Ear infection
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Endocarditis bacterial
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Gangrene
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Gastroenteritis
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Infections and infestations
Infective myositis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Localised infection
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Orchitis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Prostatic abscess
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Wound infection
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Infections and infestations
Anal abscess
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Central line infection
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Implant site infection
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Epidemic nephropathy
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Infections and infestations
Cholecystitis infective
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.25%
4/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.19%
3/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.19%
3/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Injury, poisoning and procedural complications
Head injury
|
0.12%
2/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.06%
1/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/1610
|
0.06%
1/1623
|
0.19%
3/1611
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
1/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.06%
1/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.06%
1/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/1610
|
0.12%
2/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.06%
1/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Contusion
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Wound
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.12%
2/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Epicodylitis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Injury
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Face injury
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Device failure
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Medical device complicaiton
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Lung injury
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
9/1610
|
0.80%
13/1623
|
0.68%
11/1611
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.06%
1/1610
|
0.37%
6/1623
|
0.06%
1/1611
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.12%
2/1610
|
0.18%
3/1623
|
0.12%
2/1611
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.12%
2/1610
|
0.06%
1/1623
|
0.19%
3/1611
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.06%
1/1610
|
0.06%
1/1623
|
0.25%
4/1611
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.12%
2/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
2/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Musculoskeletal and connective tissue disorders
Nose deformity
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Urinary retention
|
0.12%
2/1610
|
0.37%
6/1623
|
0.93%
15/1611
|
|
Renal and urinary disorders
Calculus ureteric
|
0.12%
2/1610
|
0.25%
4/1623
|
0.25%
4/1611
|
|
Renal and urinary disorders
Renal failure acute
|
0.31%
5/1610
|
0.12%
2/1623
|
0.19%
3/1611
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/1610
|
0.18%
3/1623
|
0.25%
4/1611
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.06%
1/1610
|
0.18%
3/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Renal failure
|
0.06%
1/1610
|
0.18%
3/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Renal colic
|
0.06%
1/1610
|
0.25%
4/1623
|
0.00%
0/1611
|
|
Renal and urinary disorders
Haematuria
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Calculus urinary
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Renal and urinary disorders
Renal failure chronic
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Renal and urinary disorders
Ureteral polyp
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Renal and urinary disorders
Renal artery arteriosclerosis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
4/1610
|
0.31%
5/1623
|
0.25%
4/1611
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
5/1610
|
0.25%
4/1623
|
0.06%
1/1611
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.25%
4/1610
|
0.06%
1/1623
|
0.19%
3/1611
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.06%
1/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.19%
3/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1610
|
0.00%
0/1623
|
0.37%
6/1611
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1610
|
0.06%
1/1623
|
0.19%
3/1611
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/1610
|
0.18%
3/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Idioipathic pulmonary fibrosis
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Allergic granulomatous angiitis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Vascular disorders
Hypertension
|
0.25%
4/1610
|
0.18%
3/1623
|
0.50%
8/1611
|
|
Vascular disorders
Aortic aneurysm
|
0.19%
3/1610
|
0.12%
2/1623
|
0.06%
1/1611
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.12%
2/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
Vascular disorders
Aortic stenosis
|
0.12%
2/1610
|
0.12%
2/1623
|
0.06%
1/1611
|
|
Vascular disorders
Aortic dissection
|
0.06%
1/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Vascular disorders
Arteriosclerosis
|
0.06%
1/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Vascular disorders
Hypotension
|
0.12%
2/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Vascular disorders
Peripheral ischaemia
|
0.12%
2/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Vascular disorders
Peripheral vascular disorder
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Vascular disorders
Varicose vein
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Vascular disorders
Malignant hypertension
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Vascular disorders
Orthostatic hypotension
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Vascular disorders
Venous stenosis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Vascular disorders
Haemorrhage
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Vascular disorders
Aortic dilatation
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Vascular disorders
Aortic disorder
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Vascular disorders
Arterial disorder
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
4/1610
|
0.37%
6/1623
|
0.37%
6/1611
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.19%
3/1610
|
0.18%
3/1623
|
0.25%
4/1611
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
3/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Hepatobiliary disorders
Hepatic mass
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
General disorders
Pyrexia
|
0.06%
1/1610
|
0.12%
2/1623
|
0.19%
3/1611
|
|
General disorders
Non-cardiac chest pain
|
0.12%
2/1610
|
0.25%
4/1623
|
0.00%
0/1611
|
|
General disorders
Chest pain
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
General disorders
Multi-organ failure
|
0.06%
1/1610
|
0.06%
1/1623
|
0.12%
2/1611
|
|
General disorders
Death
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
General disorders
Asthenia
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
General disorders
Fatigue
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
General disorders
Generalised oedema
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
General disorders
Local swelling
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
General disorders
Malaise
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
General disorders
Sudden death
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
General disorders
Implant site erosion
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1610
|
0.12%
2/1623
|
0.62%
10/1611
|
|
Reproductive system and breast disorders
Prostatitis
|
0.06%
1/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Reproductive system and breast disorders
Priapism
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Reproductive system and breast disorders
Prostatic intraepithelial neoplasia
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Eye disorders
Cataract
|
0.12%
2/1610
|
0.12%
2/1623
|
0.25%
4/1611
|
|
Eye disorders
Retinal detachment
|
0.06%
1/1610
|
0.06%
1/1623
|
0.06%
1/1611
|
|
Eye disorders
Macular degeneration
|
0.06%
1/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Eye disorders
Eye haemorrhage
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Eye disorders
Glaucoma
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Eye disorders
Retinal tear
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
3/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.06%
1/1610
|
0.12%
2/1623
|
0.12%
2/1611
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Psychiatric disorders
Depression
|
0.12%
2/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Psychiatric disorders
Anxiety
|
0.06%
1/1610
|
0.12%
2/1623
|
0.00%
0/1611
|
|
Psychiatric disorders
Completed suicide
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Psychiatric disorders
Bipolar disorder
|
0.06%
1/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Psychiatric disorders
Aggression
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Psychiatric disorders
Confusional state
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Psychiatric disorders
Delirium
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1610
|
0.12%
2/1623
|
0.06%
1/1611
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Investigations
Chest x-ray abnormal
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Investigations
Coagulation factor decreased
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Investigations
Heart rate irregular
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.12%
2/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Congenital, familial and genetic disorders
Aplasia
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Congenital, familial and genetic disorders
Hereditary sideroblastic anaemia
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Skin and subcutaneous tissue disorders
Purpura senile
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/1610
|
0.06%
1/1623
|
0.00%
0/1611
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.12%
2/1610
|
0.00%
0/1623
|
0.12%
2/1611
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/1610
|
0.00%
0/1623
|
0.06%
1/1611
|
|
Vascular disorders
Phlebitis
|
0.06%
1/1610
|
0.00%
0/1623
|
0.00%
0/1611
|
Other adverse events
| Measure |
Combination
n=1610 participants at risk
|
Dutasteride 0.5 mg
n=1623 participants at risk
|
Tamsulosin 0.4 mg
n=1611 participants at risk
|
|---|---|---|---|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.4%
167/1610
|
9.1%
147/1623
|
6.8%
109/1611
|
|
Vascular disorders
Hypertension
|
8.3%
133/1610
|
9.1%
147/1623
|
8.4%
136/1611
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
134/1610
|
7.9%
129/1623
|
9.2%
149/1611
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
107/1610
|
5.4%
88/1623
|
7.0%
113/1611
|
|
Infections and infestations
Influenza
|
4.8%
77/1610
|
4.6%
75/1623
|
5.2%
83/1611
|
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