Trial Outcomes & Findings for Actual Use Study of Tamsulosin in Men (NCT NCT02573311)
NCT ID: NCT02573311
Last Updated: 2020-04-08
Results Overview
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1117 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-04-08
Participant Flow
The trial consisted of 2 parts. One was the product review phase (Part 1) and another was the actual use phase (Part 2). The number of enrolled patients in the protocol represent the number of participants (1117) who intended to purchase study product and enter part 2 of the study. All endpoints are based on part 2 of the study.
Participant milestones
| Measure |
Cohort 1
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
Cohort 2
Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|---|
|
Disposition for Part 1
STARTED
|
1737
|
364
|
|
Disposition for Part 1
COMPLETED
|
1730
|
361
|
|
Disposition for Part 1
NOT COMPLETED
|
7
|
3
|
|
Disposition for Part 2
STARTED
|
964
|
153
|
|
Disposition for Part 2
COMPLETED
|
754
|
127
|
|
Disposition for Part 2
NOT COMPLETED
|
210
|
26
|
Reasons for withdrawal
| Measure |
Cohort 1
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
Cohort 2
Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|---|
|
Disposition for Part 1
Withdrawal by Subject
|
7
|
3
|
|
Disposition for Part 2
Physician Decision
|
25
|
7
|
|
Disposition for Part 2
Adverse Event
|
36
|
5
|
|
Disposition for Part 2
Lost to Follow-up
|
76
|
7
|
|
Disposition for Part 2
Withdrawal by Subject
|
60
|
3
|
|
Disposition for Part 2
Investigator decision
|
0
|
1
|
|
Disposition for Part 2
Other than specified above
|
13
|
3
|
Baseline Characteristics
Actual Use Study of Tamsulosin in Men
Baseline characteristics by cohort
| Measure |
Cohort 1
n=1731 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
Cohort 2
n=362 Participants
Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
Total
n=2093 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 Years
STANDARD_DEVIATION 11.67 • n=99 Participants
|
68.3 Years
STANDARD_DEVIATION 9.10 • n=107 Participants
|
63.0 Years
STANDARD_DEVIATION 11.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1731 Participants
n=99 Participants
|
362 Participants
n=107 Participants
|
2093 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set for Actual Use (FAS-AU1) included all men who were currently not using a prescription medicine for BPH, purchased the study product, took at least one dose of study drug within the first 12 weeks of purchase and participated in at least 1 phone interview within the first 12 weeks of using the study product.
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Outcome measures
| Measure |
Cohort 1
n=924 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|
|
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: FAS AU1
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL during the study (i.e., 24 weeks) and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Outcome measures
| Measure |
Cohort 1
n=924 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|
|
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set for Actual Use and Stop Use and Ask If - Condition Within the First 12 Weeks: (FAS-AU1-COND12): These populations are subsets of the FAS-AU1 population which will include all men who report a condition listed under the "Stop use and ask a doctor if" section of DFL within the first 12 weeks of using the study product.
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Outcome measures
| Measure |
Cohort 1
n=207 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|
|
Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set for Actual Use and Stop Use and Ask If - Condition Within the First 24 Weeks: (FAS-AU1-COND24): These populations are subsets of the FAS-AU1 population which will include all men who report a condition listed under the "Stop use and ask a doctor if" section of DFL within the first 24 weeks of using the study product.
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Outcome measures
| Measure |
Cohort 1
n=215 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|
|
Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks
|
0.9 Percentage of participants
Interval 0.1 to 3.3
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS AU1
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within the first 12 weeks of using the study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Outcome measures
| Measure |
Cohort 1
n=924 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|
|
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1
|
22.4 Percentage of participants
Interval 19.8 to 25.2
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: FAS AU1
Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Outcome measures
| Measure |
Cohort 1
n=924 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|
|
Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1
|
20.3 Percentage of participants
Interval 17.8 to 23.1
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set for Actual Use and Ask a Doctor Before Use (FAS-AU1-ASK) is a subset of the FAS-AU1 population which included all men who reported a symptom or condition listed under the "Ask a doctor before use" section of the DFL.
Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 who reported a symptom or condition is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Outcome measures
| Measure |
Cohort 1
n=223 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|
|
Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition
|
84.3 Percentage of participants
Interval 78.9 to 88.8
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: FAS AU1
Percentage of men who sought advice of a physician within the first 12/24 weeks of the study out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Outcome measures
| Measure |
Cohort 1
n=924 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|
|
Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1
Week 12 (N=924)
|
43.1 Percentage of participants
Interval 39.9 to 46.3
|
|
Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1
Week 24 (N=924)
|
56.4 Percentage of participants
Interval 53.1 to 59.6
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: FAS AU1
Percentage of men who took two or more capsules per day within the first 12/24 weeks of using study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Outcome measures
| Measure |
Cohort 1
n=924 Participants
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks).
|
|---|---|
|
Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1
Week 12 (N=924)
|
7.6 Percentage of participants
Interval 6.3 to 10.0
|
|
Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1
Week 24 (N=924)
|
9.5 Percentage of participants
Interval 8.1 to 12.1
|
Adverse Events
Cohort 1
Serious events: 54 serious events
Other events: 61 other events
Deaths: 0 deaths
Cohort 2
Serious events: 12 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort 1 and 2
Serious events: 66 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=927 participants at risk
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). (TS1)
|
Cohort 2
n=150 participants at risk
Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). (TS2)
|
Cohort 1 and 2
n=1077 participants at risk
Cohort 1 and 2 included all men who answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks) regardless of whether they were currently using the product or not. (TS)
|
|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Cardiac disorders
Cardiomyopathy
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.22%
2/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.28%
3/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Eye disorders
Glaucoma
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Eye disorders
Retinal detachment
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.22%
2/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.28%
3/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Anal abscess
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Appendicitis perforated
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.22%
2/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.22%
2/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.22%
2/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.22%
2/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.28%
3/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Nervous system disorders
Carotid artery disease
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Renal and urinary disorders
Calculus urinary
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.22%
2/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Surgical and medical procedures
Hospitalisation
|
0.22%
2/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.22%
2/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.67%
1/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.19%
2/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.11%
1/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.00%
0/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
0.09%
1/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
Other adverse events
| Measure |
Cohort 1
n=927 participants at risk
Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). (TS1)
|
Cohort 2
n=150 participants at risk
Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). (TS2)
|
Cohort 1 and 2
n=1077 participants at risk
Cohort 1 and 2 included all men who answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks) regardless of whether they were currently using the product or not. (TS)
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.2%
48/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
11.3%
17/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
6.0%
65/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
15/927 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
5.3%
8/150 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
2.1%
23/1077 • From the first drug administration until 3 days after the treatment phase, up to 171 days.
The Treated Set for Cohort (TS) included all men who were currently not using a prescription medicine for BPH (TS1) or were currently using a prescription medicine for BPH (TS2), purchased the study product and took at least one dose of study drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER