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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-MC-LVHG |
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| Name | Class |
|---|---|
| ICOS Corporation | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | placebo tablet |
|
| 2 | Active Comparator | 2.5 mg tadalafil tablet |
|
| 3 | Active Comparator | 5 mg tadalafil tablet |
|
| 4 | Active Comparator | 10 mg tadalafil tablet |
|
| 5 | Active Comparator | 20 mg tadalafil tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tadalafil | Drug | 2.5 mg tadalafil tablet by mouth once a day for twelve weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis | Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic. | Baseline and 12 weeks |
| Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis | Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Greenwood | Indiana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26299520 | Derived | Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24. | |
| 20163842 |
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Not provided
Prior to randomization, participants had a 1-4 week Screening/Wash-out Period, followed by a 4 week Placebo Run-In Period. 1813 participants were screened with 755 screen failures, and 1058 participants randomized. The two participants who did not receive study drug were not included in the baseline demographics table.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo tablet by mouth once a day for twelve weeks |
| FG001 | 2.5 mg Tadalafil | 2.5 mg tadalafil tablet by mouth once a day for twelve weeks |
| FG002 | 5 mg Tadalafil | 5 mg tadalafil tablet by mouth once a day for twelve weeks |
| FG003 | 10 mg Tadalafil | 10 mg tadalafil tablet by mouth once a day for twelve weeks |
| FG004 | 20 mg Tadalafil | 20 mg tadalafil tablet by mouth once a day for twelve weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo tablet by mouth once a day for twelve weeks |
| BG001 | 2.5 mg Tadalafil | 2.5 mg tadalafil tablet by mouth once a day for twelve weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis | Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic. | Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
Not provided
Not provided
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 | Placebo | placebo tablet by mouth once a day for twelve weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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| tadalafil | Drug | 5 mg tadalafil tablet by mouth once a day for twelve weeks. |
|
|
| tadalafil | Drug | 10 mg tadalafil tablet by mouth once a day for twelve weeks. |
|
|
| tadalafil | Drug | 20 mg tadalafil tablet by mouth once a day for twelve weeks. |
|
|
| placebo | Drug | Placebo tablet taken by mouth one a day for twelve weeks |
|
| baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. | 12 weeks |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) | Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia). | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index | Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) | Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16. | baseline and 12 weeks |
| Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) | LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms. | 12 weeks |
| Change From Baseline to 12 Week Endpoint in Peak Urinary Flow | Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values. | baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain | Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30. | baseline and 12 weeks |
| United States |
| Derived |
| Broderick GA, Brock GB, Roehrborn CG, Watts SD, Elion-Mboussa A, Viktrup L. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction. Urology. 2010 Jun;75(6):1452-8. doi: 10.1016/j.urology.2009.09.093. Epub 2010 Feb 16. |
| 19409693 | Derived | Porst H, McVary KT, Montorsi F, Sutherland P, Elion-Mboussa A, Wolka AM, Viktrup L. Effects of once-daily tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia. Eur Urol. 2009 Oct;56(4):727-35. doi: 10.1016/j.eururo.2009.04.033. Epub 2009 Apr 22. |
| 18722631 | Derived | Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008 Oct;180(4):1228-34. doi: 10.1016/j.juro.2008.06.079. Epub 2008 Aug 22. |
| Entry Criteria Not Met |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
| Didn't Receive Double-Blind Study Drug |
|
| BG002 | 5 mg Tadalafil | 5 mg tadalafil tablet by mouth once a day for twelve weeks |
| BG003 | 10 mg Tadalafil | 10 mg tadalafil tablet by mouth once a day for twelve weeks |
| BG004 | 20 mg Tadalafil | 20 mg tadalafil tablet by mouth once a day for twelve weeks |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline (Visit 3) Lower Urinary Tract Symptoms (LUTS) Severity | LUTS Severity was measured with the International Prostate Symptom Score (IPSS), which has a scoring range of 0 to 35. Total scores: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic. | Number | participants |
|
| Duration of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH) | Number | participants |
|
| Erectile Dysfunction | Number | participants |
|
| Previous Therapy for Benign Prostatic Hyperplasia (BPH) | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Severity of Erectile Dysfunction (ED) | Severity was determine only on participants with Erectile Dysfunction using scores on International Index of Erectile Function (IIEF) EF Domain (sum of the scores for Questions 1 through 5 and Question 15) with a range of 0 to 30. Normal EF (≥26), mild ED (17 to 25), moderate ED (11 to 16), and severe ED (1 to 10). | Number | participants |
|
| Sexually Active | Number | participants |
|
| Sexually Active and Erectile Dysfunction (ED) | Number | participants |
|
5 mg tadalafil tablet taken by mouth once a day for 12 weeks |
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) | Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia). | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index | Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) | Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Secondary | Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) | LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow | Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | milliliter per second | baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain | Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from all randomized and sexually active subjects with a history of ED and non-missing data at baseline and at least one postbaseline visit were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 weeks |
|
|
|
|
| Primary | Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis | Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic. | Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
|
|
|
|
| 6 |
| 43 |
| EG001 | 2.5 mg Tadalafil | 2.5 mg tadalafil tablet by mouth once a day for twelve weeks | 3 | 54 |
| EG002 | 5 mg Tadalafil | 5 mg tadalafil tablet by mouth once a day for twelve weeks | 1 | 65 |
| EG003 | 10 mg Tadalafil | 10 mg tadalafil tablet by mouth once a day for twelve weeks | 2 | 75 |
| EG004 | 20 mg Tadalafil | 20 mg tadalafil tablet by mouth once a day for twelve weeks | 5 | 80 |
| Atrial tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ureteric rupture | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Indwelling catheter management | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Ureteral catheterisation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Ureteral stent insertion | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Left atrial dilatation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Choroidal neovascularisation | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eyelid irritation | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ocular hypertension | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Panophthalmitis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Duodenogastric reflux | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gingival disorder | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Vertebral injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Heart rate abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Podagra | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Balanitis | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Painful erection | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Dental operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Umbilical hernia repair | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| D052801 |
| Male Urogenital Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Change from Baseline |
|
| ANCOVA |
| <0.001 |
P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. |
| Mean Difference (Net) |
| -0.90 |
| 95 |
| -1.40 |
| -0.40 |
Mean Difference = 5 mg Tadalafil minus Placebo |
| No |
| Superiority or Other |
| ANCOVA | <0.001 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -0.96 | 95 | -1.45 | -0.46 | Mean Difference = 10 mg Tadalafil minus Placebo | No | Superiority or Other |
| ANCOVA | <0.001 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -1.07 | 95 | -1.58 | -0.57 | Mean Difference = 20 mg Tadalafil minus Placebo | No | Superiority or Other |
| Change from Baseline |
|
| ANCOVA |
| <0.001 |
P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. |
| Mean Difference (Net) |
| -1.69 |
| 95 |
| -2.40 |
| -0.98 |
Mean Difference = 5 mg Tadalafil minus Placebo |
| No |
| Superiority or Other |
| ANCOVA | <0.001 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -1.89 | 95 | -2.60 | -1.18 | Mean Difference = 10 mg Tadalafil minus Placebo | No | Superiority or Other |
| ANCOVA | <0.001 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -1.87 | 95 | -2.59 | -1.15 | Mean Difference = 20 mg Tadalafil minus Placebo | No | Superiority or Other |
| Change from Baseline |
|
| ANCOVA |
| 0.206 |
P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. |
| Mean Difference (Net) |
| -0.13 |
| 95 |
| -0.34 |
| 0.07 |
Mean Difference = 5 mg Tadalafil minus Placebo |
| No |
| Superiority or Other |
| ANCOVA | 0.452 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -0.08 | 95 | -0.28 | 0.13 | Mean Difference = 10 mg Tadalafil minus Placebo | No | Superiority or Other |
| ANCOVA | 0.012 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -0.26 | 95 | -0.47 | -0.06 | Mean Difference = 20 mg Tadalafil minus Placebo | No | Superiority or Other |
| Change from Baseline |
|
| ANCOVA |
| 0.002 |
P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. |
| Mean Difference (Net) |
| -0.37 |
| 95 |
| -0.60 |
| -0.14 |
Mean Difference = 5 mg Tadalafil minus Placebo |
| No |
| Superiority or Other |
| ANCOVA | <0.001 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -0.43 | 95 | -0.66 | -0.19 | Mean Difference = 10 mg Tadalafil minus Placebo | No | Superiority or Other |
| ANCOVA | <0.001 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -0.40 | 95 | -0.64 | -0.17 | Mean Difference = 20 mg Tadalafil minus Placebo | No | Superiority or Other |
| Change from Baseline |
|
| ANCOVA |
| 0.013 |
P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. |
| Mean Difference (Net) |
| -0.57 |
| 95 |
| -1.03 |
| -0.12 |
Mean Difference = 5 mg Tadalafil minus Placebo |
| No |
| Superiority or Other |
| ANCOVA | 0.016 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -0.55 | 95 | -1.00 | -0.10 | Mean Difference = 10 mg Tadalafil minus Placebo | No | Superiority or Other |
| ANCOVA | 0.007 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -0.62 | 95 | -1.08 | -0.17 | Mean Difference = 20 mg Tadalafil minus Placebo | No | Superiority or Other |
| Cochran-Mantel-Haenszel |
| 0.003 |
P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | <0.001 | P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | <0.001 | P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons. | 95 | No | Superiority or Other |
| Change from Baseline |
|
| ANCOVA |
| 0.355 |
P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. |
| Mean Difference (Net) |
| 0.39 |
| 95 |
| -0.44 |
| 1.23 |
Mean Difference = 5 mg Tadalafil minus Placebo |
| No |
| Superiority or Other |
| ANCOVA | 0.433 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | 0.34 | 95 | -0.50 | 1.17 | Mean Difference = 10 mg Tadalafil minus Placebo | No | Superiority or Other |
| ANCOVA | 0.089 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | 0.74 | 95 | -0.11 | 1.59 | Mean Difference = 20 mg Tadalafil minus Placebo | No | Superiority or Other |
| Change from Baseline |
|
| ANCOVA |
| <0.001 |
P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. |
| Mean Difference (Net) |
| 4.75 |
| 95 |
| 2.95 |
| 6.54 |
Mean Difference = 5 mg Tadalafil minus Placebo |
| No |
| Superiority or Other |
| ANCOVA | <0.001 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | 5.83 | 95 | 4.04 | 7.62 | Mean Difference = 10 mg Tadalafil minus Placebo | No | Superiority or Other |
| ANCOVA | <0.001 | P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | 6.15 | 95 | 4.35 | 7.95 | Mean Difference = 20 mg Tadalafil minus Placebo | No | Superiority or Other |
|
This is a supportive analysis of the primary outcome. |
| ANCOVA |
| <0.001 |
P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons. |
| Mean Difference (Net) |
| -2.60 |
| 95 |
| -3.69 |
| -1.51 |
Mean Difference = 5 mg Tadalafil minus Placebo |
| No |
| Superiority or Other |
| This is a supportive analysis of the primary outcome. | ANCOVA | <0.001 | P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -2.90 | 95 | -3.99 | -1.81 | Mean Difference = 10 mg Tadalafil minus Placebo | No | Superiority or Other |
| This is a supportive analysis of the primary outcome. | ANCOVA | <0.001 | P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons. | Mean Difference (Net) | -2.94 | 95 | -4.04 | -1.84 | Mean Difference = 20 mg Tadalafil minus Placebo | No | Superiority or Other |