Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Me... | NCT00783094 | Trialant
NCT00783094
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Mar 29, 2011Estimated
Enrollment
422Actual
Phase
Phase 2
Conditions
Benign Prostatic Hyperplasia
Interventions
Tadalafil 2.5 mg
Tadalafil 5 mg
Placebo
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT00783094
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12757
Secondary IDs
ID
Type
Description
Link
H6D-JE-LVIA
Other Identifier
Eli Lilly and Company
Brief Title
Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks Followed by an Open-Label Extension to Evaluate the Long-Term Safety and Efficacy of Tadalafil in Japanese Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2008
Primary Completion Date
Jun 2009Actual
Completion Date
Apr 2010Actual
First Submitted Date
Oct 30, 2008
First Submission Date that Met QC Criteria
Oct 30, 2008
First Posted Date
Oct 31, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 25, 2010
Results First Submitted that Met QC Criteria
Jun 25, 2010
Results First Posted Date
Jul 28, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 18, 2011
Last Update Posted Date
Mar 29, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.
Detailed Description
Not provided
Conditions Module
Conditions
Benign Prostatic Hyperplasia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
422Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Tadalafil 2.5 milligrams (mg)
Experimental
2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Drug: Tadalafil 2.5 mg
Tadalafil 5 mg
Experimental
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Drug: Tadalafil 5 mg
Placebo
Placebo Comparator
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tadalafil 2.5 mg
Drug
oral, daily
Tadalafil 2.5 milligrams (mg)
LY450190
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
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.
Baseline, 12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Baseline, 12 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.
Exclusion Criteria:
Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
Clinical evidence of prostate cancer at Visit 1.
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
45 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
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
Locations
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.
Chiba
274-0825
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Baseline, 12 weeks
Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Baseline, 12 weeks
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Baseline, 12 weeks
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.
Baseline, 12 weeks
Number of Participants With Adverse Events During 12 Weeks of the Study
A listing of Adverse Events are reported in the Reported Adverse Event Section.
Baseline through 12 weeks
Change From Baseline in Blood Pressure at 12-Week Endpoint
Baseline, 12 weeks
Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
Baseline, 12 Weeks
Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.
Baseline, 12 weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Baseline, 12 weeks
Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
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.
Baseline, 54 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Baseline, 54 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Baseline, 54 weeks
Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Baseline, 54 weeks
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Baseline, 54 weeks
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Baseline, 54 weeks
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
A listing of Adverse Events are reported in the Reported Adverse Event Section.
End of 12 weeks of double-blind through 54 weeks
Change From Baseline in Blood Pressure During at 54-Week Endpoint
Baseline, 54 weeks
Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
Baseline, 54-weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Baseline, 54 weeks
Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
Post residual volume (PVR) is measured by ultrasound at regular intervals.
Baseline, 54 weeks
Japan
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.
Hiroshima
730-0013
Japan
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.
Kanagawa
226-0025
Japan
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.
Kyoto
607-8085
Japan
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.
Osaka
561-0832
Japan
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.
Tokyo
150-0002
Japan
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
FG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
FG000142 subjects
FG001140 subjects
FG002140 subjects
COMPLETED
FG000135 subjects
FG001128 subjects
FG002131 subjects
NOT COMPLETED
FG0007 subjects
FG00112 subjects
FG0029 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0015 subjects
FG0025 subjects
Lack of Efficacy
FG0000 subjects
FG0012 subjects
FG0021 subjects
Physician Decision
FG0000 subjects
FG0012 subjects
FG0020 subjects
Protocol Violation
FG0001 subjects
FG0012 subjects
FG0021 subjects
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0022 subjects
Open-Label Extension Period
Type
Comment
Milestone Data
STARTED
FG000135 subjects
FG001128 subjects
FG002131 subjects
COMPLETED
FG000113 subjects
FG001109 subjects
FG002101 subjects
NOT COMPLETED
FG00022 subjects
FG00119 subjects
FG00230 subjects
Type
Comment
Reasons
Adverse Event
FG00012 subjects
FG0017 subjects
FG00216 subjects
Death
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
BG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
BG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Participants with BPH were defined as having had signs and symptoms of benign prostatic hyperplasia (BPH) (as diagnosed by a qualified physician) >6 months at Visit 1. Signs and symptoms of BPH included those associated with voiding (obstructive symptoms, such as incomplete emptying, intermittency, weak stream, straining)and/or storage (irritative symptoms, such as frequency, urgency, or nocturia).
Number
participants
Title
Denominators
Categories
Moderate
Title
Measurements
BG000100
BG001
Current Alcohol Use
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00096
BG00192
BG002
Current Tobacco Use
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00031
BG00128
BG002
Previous Alpha-blocker Use
Actual use of alpha-blockers within the previous 12 months.
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG000111
BG001108
BG002
Previous Benign Prostatic Hyperplasia Therapy
Actual benign prostatic hyperplasia (BPH) therapy within the previous 12 months.
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00027
BG00133
BG002
Previous Overactive Bladder Therapy
Actual overactive bladder (OAB) therapy within the previous 12 months.
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00010
BG00112
BG002
Body Mass Index
Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.
Mean
Standard Deviation
kilograms/meters squared
Title
Denominators
Categories
Title
Measurements
BG00023.3± 2.4
BG00123.5± 2.6
Duration of BPH
Participants had signs and symptoms of benign prostatic hyperplasia (BPH) (as diagnosed by a qualified physician) >6 months at Visit 1.
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0004.1± 3.0
BG0014.5
Height
Mean
Standard Deviation
centimeters
Title
Denominators
Categories
Title
Measurements
BG000166.0± 5.9
BG001166.9± 6.1
BG002
Postvoid Residual Volume
Postvoid residual volume (PVR) was measured by ultrasound at regular intervals.
Mean
Standard Deviation
mililiters
Title
Denominators
Categories
Title
Measurements
BG00035.2± 46.6
BG00132.2± 36.4
Weight
Mean
Standard Deviation
kilograms
Title
Denominators
Categories
Title
Measurements
BG00064.4± 8.6
BG00165.4± 8.3
BG002
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 in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint
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.
Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
OG000142
OG001140
OG002139
Title
Denominators
Categories
Title
Measurements
OG000-4.5± 0.4
OG001-4.9± 0.4
OG002-3.8± 0.4
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
OG002
ANCOVA
With effects for treatment, prior alpha blocker use (yes/no), and baseline value.
0.201
Mean Difference (Final Values)
-0.7
Standard Error of the Mean
0.6
2-Sided
95
-1.8
0.4
Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo
No
Superiority or Other
OG001
Secondary
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Secondary
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Secondary
Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Secondary
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Secondary
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.
Posted
Least Squares Mean
Standard Error
milliliters per second
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Secondary
Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement
Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.
Participants who received 2.5 mg or 5 mg tadalafil once daily during the double-blind period.
Posted
Apr 2011
Geometric Mean
Standard Deviation
nanogram/milliliter
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Adverse Events During 12 Weeks of the Study
A listing of Adverse Events are reported in the Reported Adverse Event Section.
All randomized participants
Posted
Number
participants
Baseline through 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in Blood Pressure at 12-Week Endpoint
Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.
Posted
Mean
Standard Deviation
mmHg
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in Sitting Heart Rate at 12-Week Endpoint
Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.
Posted
Mean
Standard Deviation
beats per minute
Baseline, 12 Weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint
Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.
Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.
Posted
Mean
Standard Deviation
milliliters
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
Safety Analysis Set: All randomized participants who received study treatment grouped by the treatment actually taken.
Posted
Mean
Standard Deviation
Micrograms per liter
Baseline, 12 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint
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.
All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
units on a scale
Baseline, 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Secondary
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.
All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
units on a scale
Baseline, 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Secondary
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.
All participants enrolled in the open-label phase who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
units on a scale
Baseline, 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Secondary
Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint
Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
units on a scale
Baseline, 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Secondary
Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint
The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.
All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
units on a scale
Baseline, 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Secondary
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint
Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).
All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
units on a scale
Baseline, 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Secondary
Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment
A listing of Adverse Events are reported in the Reported Adverse Event Section.
All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Posted
Apr 2011
Number
participants
End of 12 weeks of double-blind through 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in Blood Pressure During at 54-Week Endpoint
All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
millimeters of mercury (mmHg)
Baseline, 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in Sitting Heart Rate at 54-Week Endpoint
All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
beats per minute (bpm)
Baseline, 54-weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint
Measurement of nanograms of PSA per milliliter (ng/mL) of blood.
All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
microgram/liter
Baseline, 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Secondary
Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint
Post residual volume (PVR) is measured by ultrasound at regular intervals.
All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.
Posted
Apr 2011
Mean
Standard Deviation
milliliter
Baseline, 54 weeks
ID
Title
Description
OG000
Tadalafil 2.5 mg
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG001
Tadalafil 5 mg
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
OG002
Placebo
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Units
Counts
Participants
Time Frame
Treatment-emergent adverse events (TEAEs) - defined as events that 1st occurred/worsened after randomization at Week 0.
Description
Post-baseline period began after enrollment (Week 12) in open-label extension. If subject reports the occurrence of an event more than once, the most severe of those events was used to determine if event was TE. Analysis of TEAEs was summarized for open-label extension alone (Weeks 12-54). Week 0 of double-blind treatment period was baseline.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Tadalafil 2.5 mg - Double-Blind Phase
2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks in the Open-Label Phase.
2
142
52
142
EG001
Tadalafil 5 mg - Double-Blind Phase
5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
2
140
54
140
EG002
Placebo - Double-Blind Phase
Placebo tablet taken by mouth once a day for 12 weeks.
Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
1
140
53
140
EG003
Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label
5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 2.5 mg tadalafil in the double-blind phase.
3
135
81
135
EG004
Tadalafil 5 mg: Tadalafil 5 mg Open-Label
5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 5 mg tadalafil in the double-blind phase.
4
128
81
128
EG005
Placebo: Tadalafil 5 mg Open-Label
5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received placebo in the double-blind phase.
4
131
94
131
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG0030 events0 affected135 at risk
EG0040 events0 affected128 at risk
EG0050 events0 affected131 at risk
Cardiac failure
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Retinal detachment
Eye disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Traumatic arthritis
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arrhythmia
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG0030 events0 affected135 at risk
EG0040 events0 affected128 at risk
EG0050 events0 affected131 at risk
Palpitations
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Cataract
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0013 events3 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Eye discharge
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Macular hole
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Vision blurred
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0012 events2 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected142 at risk
EG0012 events2 affected140 at risk
EG0025 events5 affected140 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected142 at risk
EG0014 events4 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected142 at risk
EG0012 events2 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Gastritis atrophic
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Periodontitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Periproctitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Reflux oesophagitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected142 at risk
EG0012 events2 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0022 events1 affected140 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Chest pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Cyst
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Oedema
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Pyrexia
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Thirst
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Xerosis
General disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0011 events1 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Empyema
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Influenza
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG00011 events11 affected142 at risk
EG00114 events14 affected140 at risk
EG00219 events18 affected140 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Otitis media
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0011 events1 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0012 events2 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Occult blood positive
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Tumour marker increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0003 events2 affected142 at risk
EG0012 events2 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0012 events2 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0012 events2 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0002 events2 affected142 at risk
EG0013 events3 affected140 at risk
EG0023 events3 affected140 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Nipple disorder
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0023 events3 affected140 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Colon polypectomy
Surgical and medical procedures
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Dental implantation
Surgical and medical procedures
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Gastrointestinal tube insertion
Surgical and medical procedures
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Internal fixation of fracture
Surgical and medical procedures
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0012 events2 affected140 at risk
EG0022 events2 affected140 at risk
EG003
Ureteral catheterisation
Surgical and medical procedures
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0011 events1 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Flushing
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Hot flush
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0003 events3 affected142 at risk
EG0012 events2 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Hypertension
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0021 events1 affected140 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected142 at risk
EG0010 events0 affected140 at risk
EG0020 events0 affected140 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D011470
Prostatic Hyperplasia
Ancestor Terms
ID
Term
D011469
Prostatic Diseases
D005832
Genital Diseases, Male
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068581
Tadalafil
Ancestor Terms
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
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0010 subjects
FG0021 subjects
Protocol Violation
FG0004 subjects
FG0015 subjects
FG0027 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0023 subjects
Physician Decision
FG0004 subjects
FG0012 subjects
FG0023 subjects
Lack of Efficacy
FG0001 subjects
FG0014 subjects
FG0020 subjects
66.8
± 7.3
0
BG0030
Male
BG000142
BG001140
BG002140
BG003422
140
BG003422
140
BG003422
102
BG002100
BG003302
Severe
Title
Measurements
BG00042
BG00138
BG00240
BG003120
93
BG003281
No
Title
Measurements
BG00046
BG00148
BG00247
BG003141
25
BG00384
No
Title
Measurements
BG00061
BG00172
BG00270
BG003203
Unknown or Not Recorded
Title
Measurements
BG00050
BG00140
BG00245
BG003135
106
BG003325
No
Title
Measurements
BG00031
BG00132
BG00234
BG00397
23
BG00383
No
Title
Measurements
BG000115
BG001107
BG002117
BG003339
7
BG00329
No
Title
Measurements
BG000132
BG001128
BG002133
BG003393
BG00223.6± 2.9
BG00323.5± 2.6
± 3.3
BG0024.1± 2.9
BG0034.2± 3.1
166.3
± 6.3
BG003166.4± 6.1
BG00231.6± 42.7
BG00333.0± 42.1
65.4
± 10.2
BG00365.1± 9.1
OG002
ANCOVA
With effects for treatment, prior alpha blocker use (yes/no) and baseline value.
0.062
Mean Difference (Final Values)
-1.1
Standard Error of the Mean
0.6
2-Sided
95
-2.2
0.1
Least Squares Mean Difference = Tadalafil 5 mg - Placebo.
No
Superiority or Other
Units
Counts
Participants
OG000142
OG001140
OG002139
Title
Denominators
Categories
Title
Measurements
OG000-1.6± 0.2
OG001-1.6± 0.2
OG002-1.4± 0.2
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
OG002
ANCOVA
With effects for treatment, prior alpha blocker use (yes/no) and baseline value.
0.356
Mean Difference (Final Values)
-0.2
Standard Error of the Mean
0.2
2-Sided
95
-0.7
0.2
Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.
No
Superiority or Other
OG001
OG002
ANCOVA
With effects for treatment, prior alpha blocker use (yes/no) and baseline value.
0.487
Mean Difference (Final Values)
-0.2
Standard Error of the Mean
0.2
2-Sided
95
-0.6
0.3
Least Squares Mean Difference = Tadalafil 5 mg - Placebo.
No
Superiority or Other
Units
Counts
Participants
OG000142
OG001140
OG002139
Title
Denominators
Categories
Title
Measurements
OG000-2.9± 0.3
OG001-3.3± 0.3
OG002-2.4± 0.3
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
OG002
ANCOVA
With effects for treatment, prior alpha blocker use (yes/no) and baseline value.
0.228
Mean Difference (Final Values)
-0.5
Standard Error of the Mean
0.4
2-Sided
95
-1.3
0.3
Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo
No
Superiority or Other
OG001
OG002
ANCOVA
With effects for treatment, prior alpha blocker use (yes/no) and baseline value.
0.033
Mean Difference (Final Values)
-0.9
Standard Error of the Mean
0.4
2-Sided
95
-1.7
-0.1
Least Squares Mean Difference = Tadalafil 5 mg - Placebo.
No
Superiority or Other
Participants
OG000142
OG001140
OG002139
Title
Denominators
Categories
Title
Measurements
OG000-0.5± 0.1
OG001-0.7± 0.1
OG002-0.4± 0.1
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
OG002
ANCOVA
With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.
0.249
Mean Difference (Final Values)
-0.2
Standard Error of the Mean
0.1
2-Sided
95
-0.4
0.1
Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.
No
Superiority or Other
OG001
OG002
ANCOVA
With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no) and baseline value.
0.022
Mean Difference (Final Values)
-0.3
Standard Error of the Mean
0.1
2-Sided
95
-0.6
-0.0
Least Squares Mean Difference = Tadalafil 5 mg - Placebo.
No
Superiority or Other
Units
Counts
Participants
OG000142
OG001140
OG002139
Title
Denominators
Categories
Title
Measurements
OG000-0.7± 0.1
OG001-0.8± 0.1
OG002-0.7± 0.1
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
OG002
ANCOVA
with effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.
0.904
Mean Difference (Final Values)
-0.0
Standard Error of the Mean
0.2
2-Sided
95
-0.4
0.3
Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.
No
Superiority or Other
OG001
OG002
ANCOVA
With effects for treatment, BPH severity(moderate/severe), prior alpha blocker use (yes/no), and baseline value.
0.800
Mean Difference (Final Values)
-0.0
Standard Error of the Mean
0.2
2-Sided
95
-0.4
0.3
No
Superiority or Other
Participants
OG000140
OG001135
OG002136
Title
Denominators
Categories
Title
Measurements
OG0000.7± 0.3
OG0010.6± 0.3
OG0021.4± 0.3
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
OG002
ANCOVA
With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.
0.147
Mean Difference (Final Values)
-0.6
Standard Error of the Mean
0.4
2-Sided
95
-1.5
0.2
Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.
No
Superiority or Other
OG001
OG002
ANCOVA
With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.
0.094
Mean Difference (Final Values)
-0.7
Standard Error of the Mean
0.4
2-Sided
95
-1.6
0.1
Least Squares Mean Difference = Tadalafil 5 mg - Placebo.