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An actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated Over the Counter (OTC) setting including following "stop use and ask a doctor if" and "ask a doctor before use" statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated OTC use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| men | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamsulosin hydrochloride | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Discount Drugs | Birmingham | Alabama | 35215 | United States | ||
| Homewood Pharmacy |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Disposition for Part 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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. | Week 12 |
| 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 | 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. | Week 24 |
| 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 | 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 | 12 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 | 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. | 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 | 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. | 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 | 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 | Week 12 and Week 24 |
| 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 | 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 | Week 12 and Week 24 |
| Homewood |
| Alabama |
| 35209 |
| United States |
| Robert's Discount Pharmacy | Hoover | Alabama | 35226 | United States |
| Pharmacy at the Pig | McCalla | Alabama | 35111 | United States |
| Pinson Discount Drugs | Pinson | Alabama | 35126 | United States |
| ACACIA Apothecary and Wellness | Tucson | Arizona | 85704 | United States |
| Parkview Compounding Pharmacy | Rancho Cucamonga | California | 91730 | United States |
| Garden Drug | Fort Lauderdale | Florida | 33309 | United States |
| Pill Box Pharmacy | Pembroke Pines | Florida | 33026 | United States |
| Sutton Family Pharmacy | Dalton | Georgia | 30721 | United States |
| Huff's Drug Store | Ellijay | Georgia | 30540 | United States |
| Wynn's Pharmacy Incorporated | Griffin | Georgia | 30224 | United States |
| Family Care Pharmacy | Highland | Illinois | 62249 | United States |
| Goodrich Pharmacy | Andover | Minnesota | 55304 | United States |
| Goodrich Pharmacy | Blaine | Minnesota | 55434 | United States |
| Goodrich Pharmacy | Elk River | Minnesota | 55330 | United States |
| Northfield Pharmacy | Northfield | Minnesota | 55057 | United States |
| Cub Pharmacy #1924 | Saint Louis Park | Minnesota | 55426 | United States |
| The Medicine Shoppe and Elsberry Pharmacy | Elsberry | Missouri | 63343 | United States |
| Albers' Specialty Pharmacy | Kansas City | Missouri | 64111 | United States |
| Apex Specialty Pharmacy | Riverside | Missouri | 64150 | United States |
| Stevenson Family Pharmacy | Saint Joseph | Missouri | 64504 | United States |
| Countryside Pharmacy | Savannah | Missouri | 64485 | United States |
| Texas Road Pharmacy | Monroe | New Jersey | 08831 | United States |
| Duran Central Pharmacy | Albuquerque | New Mexico | 87104 | United States |
| Sam's Regent Pharmacy | Albuquerque | New Mexico | 87109 | United States |
| Total Care Pharmacy | Burlington | North Carolina | 27215 | United States |
| Kroger Pharmacy #342 | Cary | North Carolina | 27513 | United States |
| Charleston Pharmacy, South Charleston | South Charleston | Ohio | 45368 | United States |
| Med Center Compounding Pharmacy & Health Center | Cleveland | Tennessee | 37311 | United States |
| T.B. Bond Pharmacy | Hillsboro | Texas | 76645 | United States |
| Eagle Pharmacy | Houston | Texas | 77099 | United States |
| Mountain West Apothecary | Bountiful | Utah | 84010 | United States |
| Maple Mountain Pharmacy | Mapleton | Utah | 84664 | United States |
| The Medicine Shoppe | Ogden | Utah | 84401 | United States |
| Family Plaza Pharmacy | West Jordan | Utah | 84088 | United States |
| Foothills Compounding Pharmacy | Enumclaw | Washington | 98022 | United States |
| Kelley-Ross Compounding Pharmacy | Seattle | Washington | 98104 | United States |
| Rxtra Care | Seattle | Washington | 98115 | United States |
| Kusler's Compounding Pharmacy | Snohomish | Washington | 98290 | United States |
| 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Disposition for Part 2 |
|
|
Analysis Set for Cohort 1 and 2: This set included all men who were currently not using a prescription medicine for BPH (Cohort 1) or were currently using a prescription medicine for BPH (Cohort 2) and who answered the purchase question in Part 1. (Age is missing for 8 men)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks |
|
|
| |||||||||||||||||||||||||
| Secondary | 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 | 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. | FAS AU1 | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | 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 | FAS AU1 | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | 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. | FAS AU1 | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | 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 | FAS AU1 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 and Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | 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 | FAS AU1 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 and Week 24 |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). (TS1) | 54 | 927 | 61 | 927 | ||
| EG001 | 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). (TS2) | 12 | 150 | 25 | 150 | ||
| EG002 | Cohort 1 and 2 | 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) | 66 | 1,077 | 86 | 1,077 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Investigator decision |
|
| Other than specified above |
|
| Male |
|
|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
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