A Study of Tadalafil in Men With Benign Prostatic Hyperpl... | NCT00848081

ID	Type	Description	Link
H6D-MC-LVHS	Other Identifier	Eli Lilly and Company

Status Module

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Tadalafil	Experimental		Drug: Tadalafil

Name	Type	Description	Arm Group Labels	Other Names
Tadalafil	Drug	5 mg taken by mouth once daily for 12 weeks	Tadalafil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Men With Treatment-emergent Dizziness	The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.	Baseline through 12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit	A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.

Eligibility Module

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 hourse, 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.		Huntsville	Alabama	35801

ID	Title	Description
FG000	Placebo	Placebo by mouth once daily for 12 weeks
FG001	Tadalafil	Tadalafil 5 mg taken by mouth once daily for 12 weeks

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

Number of Men With Treatment-emergent Dizziness

The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.

Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication.

Posted

Number

Participants

Baseline through 12 Weeks

ID	Title	Description
OG000	Placebo	Placebo by mouth once daily for 12 weeks
OG001	Tadalafil	Tadalafil 5 mg taken by mouth once daily for 12 weeks

Units	Counts
Participants	OG000159 OG001158

Title

Denominators

Categories

Title	Measurements
	OG0009 OG00111

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The p-value is from a one-sided Fisher's exact test with a significance level of 0.05. A total of 142 subjects per treatment arm would provide 91% power to detect the difference between a Group 1 proportion of 0.03 and a Group 2 proportion of 0.13.	Fisher Exact		0.403	1-sided test												No	Superiority or Other

Secondary

Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit

A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.

All randomized subjects in the analysis population with non-missing data.

Posted

Number

Participants

Baseline through 12 Weeks

ID	Title	Description
OG000	Placebo	Placebo by mouth once daily for 12 weeks
OG001	Tadalafil	Tadalafil 5 mg taken by mouth once daily for 12 weeks

Units	Counts
Participants

Secondary

International Prostate Symptom Score (IPSS) Change From Baseline

Change from baseline to endpoint in IPSS Score. The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication and had non-missing baseline and endpoint data.

Posted

Mean

Standard Deviation

units on a scale

Baseline, 12 Weeks

ID	Title	Description
OG000	Placebo	Placebo by mouth once daily for 12 weeks
OG001	Tadalafil	Tadalafil 5 mg taken by mouth once daily for 12 weeks

Units	Counts
Participants	OG000

Secondary

Postvoid Residual Volume (PVR) Change From Baseline

Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.

All randomized subjects who had non-missing baseline and endpoint data.

Posted

Mean

Standard Deviation

milliliters

Baseline, 12 Weeks

ID	Title	Description
OG000	Placebo	Placebo by mouth once daily for 12 weeks
OG001	Tadalafil	Tadalafil 5 mg taken by mouth once daily for 12 weeks

Units	Counts
Participants	OG000

Secondary

Uroflowmetry (Qmax) Change From Baseline

Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).

All randomized subjects with non-missing data.

Posted

Mean

Standard Deviation

milliliters per second

Baseline, 12 Weeks

ID	Title	Description
OG000	Placebo	Placebo by mouth once daily for 12 weeks
OG001	Tadalafil	Tadalafil 5 mg taken by mouth once daily for 12 weeks

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Deafness	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Ear congestion	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0012 events1 affected158 at risk
Conjunctivitis	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Eye haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Eye swelling	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Vision blurred	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0013 events2 affected158 at risk
Visual acuity reduced	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0010 events0 affected158 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0015 events5 affected158 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0019 events8 affected158 at risk
Eructation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Flatulence	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0014 events4 affected158 at risk
Gingival disorder	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Lip blister	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0014 events3 affected158 at risk
Toothache	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0010 events0 affected158 at risk
Chest discomfort	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Cyst	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0013 events3 affected158 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0011 events1 affected158 at risk
Suprapubic pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Temperature intolerance	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Seasonal allergy	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Diverticulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Ear infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Eye infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0012 events2 affected158 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Herpes zoster	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Oral herpes	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0011 events1 affected158 at risk
Sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 events2 affected160 at risk EG0011 events1 affected158 at risk
Tinea infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected160 at risk EG0010 events0 affected158 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0010 events0 affected158 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Whiplash injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0010 events0 affected158 at risk
Blood pressure decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Blood uric acid increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Colonoscopy	Investigations	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected160 at risk EG0010 events0 affected158 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Electrocardiogram abnormal	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Heart rate increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Oesophagogastroduodenoscopy	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0014 events4 affected158 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0011 events1 affected158 at risk
Loose body in joint	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0010 events0 affected158 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0012 events2 affected158 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00010 events8 affected160 at risk EG00114 events10 affected158 at risk
Dizziness postural	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected160 at risk EG0012 events2 affected158 at risk
Nerve compression	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Syncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Tension headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Anxiety	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Dysuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0003 events1 affected160 at risk EG0011 events1 affected158 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Nocturia	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0011 events1 affected158 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected160 at risk EG0011 events1 affected158 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Urine flow decreased	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Genital discomfort	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected160 at risk EG0010 events0 affected158 at risk
Testicular mass	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0012 events2 affected158 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected160 at risk EG0011 events1 affected158 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0012 events2 affected158 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0012 events2 affected158 at risk
Colon polypectomy	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Rotator cuff repair	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Skin lesion excision	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Flushing	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D026121	Indole Alkaloids
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006575	Heterocyclic Compounds, 3-Ring

ID	Title	Description
BG000	Placebo	Placebo by mouth once daily for 12 weeks
BG001	Tadalafil	Tadalafil 5 mg taken by mouth once daily for 12 weeks
BG002	Total	Total of all reporting groups

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 by mouth once daily for 12 weeks			3	160	53	160
EG001	Tadalafil	Tadalafil 5 mg taken by mouth once daily for 12 weeks			2	158	65	158

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk
Non-cardiac chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0011 events1 affected158 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Lead dislodgement	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected160 at risk EG0010 events0 affected158 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected160 at risk EG0011 events1 affected158 at risk