A Study of LY900010 in Erectile Dysfunction
Study Details
Study Description
Brief Summary
The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED) who incompletely respond to tadalafil alone.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 milligram (mg) LY2452473 + 5 mg tadalafil
|
Drug: LY2452473
Administered orally, once daily for 12 weeks
Drug: tadalafil
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
|
Experimental: 5 mg LY2452473 + 5 mg tadalafil
|
Drug: LY2452473
Administered orally, once daily for 12 weeks
Drug: tadalafil
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
|
Experimental: 5 mg LY2452473 + placebo
|
Drug: LY2452473
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
|
Active Comparator: 10 mg tadalafil + placebo
|
Drug: tadalafil
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
Drug: placebo (LY2452473)
Administered orally, once daily for 12 weeks
|
Active Comparator: 5 mg tadalafil + placebo
|
Drug: tadalafil
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
Drug: placebo (LY2452473)
Administered orally, once daily for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score [Baseline, Week 12]
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Secondary Outcome Measures
- Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary [Baseline, Week 12]
The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value <0.25).
- Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) [Baseline, Week 12]
Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
- Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25) [Baseline, Week 12]
The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to >25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
- Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups [Baseline, Week 12]
The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (<340 nanograms per deciliter [ng/dL] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline*treatment interaction (if p-value<0.25).
- Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) [Baseline, Week 12]
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
- Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides [Baseline, Week 12]
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
- Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) [Baseline, Week 12]
The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
- Change From Baseline to 12 Week Endpoint in Fasting Glucose [Baseline, Week 12]
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
- Change From Baseline to 12 Week Endpoint in Fasting Insulin [Baseline, Week 12]
Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Eligibility Criteria
Criteria
Inclusion Criteria include:
-
Ambulatory men
-
History of erectile dysfunction of at least 3 months duration
-
History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at the maximum tolerated dose within the label
-
Anticipate having the same female sexual partner throughout the duration of the study
-
Are willing and able to make at least 4 sexual intercourse attempts with the female sexual partner during each 4-week segment of the study
-
Agree to use birth control during the study and for 60 days after the study, unless the female partner is postmenopausal
-
Agree not to use any other erectile dysfunction treatment, including herbal treatment, during the study and for 96 hours after the last dose of study drug
-
Screening laboratory tests within normal limits except for testosterone
-
Without a language barrier, are reliable and willing to follow study procedures
-
Prostate-specific antigen (PSA) less than 10 nanograms per milliliter (ng/ml). Men with PSA greater than 4 and less than 10 ng/ml must have documentation of a negative histological biopsy of carcinoma of prostate within 12 months prior to screening
Exclusion Criteria include:
-
History of penile implant
-
History of no response to injection therapy for erectile dysfunction
-
History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection
-
Exhibit the presence of clinically significant penile deformity in the opinion of the investigator
-
History of prior sexual legal convictions
-
Bilateral hip replacements
-
History of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin
-
Chronic stable angina currently treated with long-acting nitrates
-
Chronic stable angina requiring treatment with short-acting nitrates within 90 days prior to screening
-
Angina occurring during sexual intercourse in the 6 months prior to screening
-
Unstable angina within 6 months prior to screening
-
Myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening
-
Angioplasty or stent placement within 90 days prior to screening
-
Congestive heart failure within 6 months prior to screening
-
History of sudden cardiac arrest
-
Supraventricular arrhythmia with an uncontrolled ventricular response at rest, or any history of spontaneous or induced sustained ventricular tachycardia, or use an automatic internal cardioverter-defibrillator
-
An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator places the subject in an unacceptable risk for study participation
-
Systolic blood pressure greater than 170 or less than 90 millimeters of mercury (mm Hg) or diastolic blood pressure greater than 100 or less than 50 mm Hg at screening
-
Hepatic, renal, human immunodeficiency virus (HIV), or clinically significant active neuropsychiatric disease
-
History of central nervous system injuries (including stroke or spinal cord injury) within 6 months prior to screening
-
Alcohol intake of 5 units or greater per day (1 unit = 12 ounces beer, 5 ounces wine, or 1.5 ounces of 80-proof distilled spirits)
-
Receiving treatment with antiandrogens or 5-alpha reductase inhibitor
-
Anabolic steroids, calcitonin, oral bisphosphonates, Vitamin D greater than 50,000 international units per week (IU/week), dehydroepiandrosterone (DHEA), steroidal supplements, nutritional products intended to have weight reduction or performance enhancing effects, herbal supplements within 7 days prior to screening
-
Currently treated with a potent cytochrome P450 (CYP) 3A4 inhibitor, such as systemic ketoconazole or ritonavir, or a CYP3A4 inducer such as rifampicin
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | 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. | Birmingham | Alabama | United States | 35209 |
2 | 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. | Phoenix | Arizona | United States | 85050 |
3 | 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. | Glendora | California | United States | 91741 |
4 | 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. | Irvine | California | United States | 92618 |
5 | 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. | Long Beach | California | United States | 90806 |
6 | 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. | Newport Beach | California | United States | 92660 |
7 | 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. | Sacramento | California | United States | 95825 |
8 | 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. | San Diego | California | United States | 92120 |
9 | 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. | Vacaville | California | United States | 95688 |
10 | 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. | Denver | Colorado | United States | 80220 |
11 | 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. | Englewood | Colorado | United States | 80113 |
12 | 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. | Aventura | Florida | United States | 33180 |
13 | 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. | Celebration | Florida | United States | 34747 |
14 | 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. | Coral Springs | Florida | United States | 33065 |
15 | 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. | Jacksonville | Florida | United States | 32209 |
16 | 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. | Plantation | Florida | United States | 33317 |
17 | 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. | Coeur d'Alene | Idaho | United States | 83814 |
18 | 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. | Indianapolis | Indiana | United States | 46256 |
19 | 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. | Des Moines | Iowa | United States | 50314 |
20 | 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. | Overland Park | Kansas | United States | 66215 |
21 | 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. | Topeka | Kansas | United States | 66606 |
22 | 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. | Shreveport | Louisiana | United States | 71106 |
23 | 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. | Troy | Michigan | United States | 48084 |
24 | 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. | Saint Louis | Missouri | United States | 63141 |
25 | 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. | Las Vegas | Nevada | United States | 89117 |
26 | 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. | Cary | North Carolina | United States | 27511 |
27 | 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. | Charlotte | North Carolina | United States | 28207 |
28 | 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. | Raleigh | North Carolina | United States | 27607 |
29 | 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. | Salisbury | North Carolina | United States | 28144 |
30 | 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. | Edmond | Oklahoma | United States | 73034 |
31 | 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. | Knoxville | Tennessee | United States | 37920 |
32 | 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. | Dallas | Texas | United States | 75234 |
33 | 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. | San Antonio | Texas | United States | 78229 |
34 | 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. | Bellevue | Washington | United States | 98007 |
35 | 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. | Olympia | Washington | United States | 98502 |
36 | 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. | Spokane | Washington | United States | 99202 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11888
- I4K-MC-GPEC
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | The study had 2 periods. Period 1: a screening, a 4-week washout, and a 4-week lead-in period prior to randomization. Period 2: a 12-week treatment and a 4-week follow-up period, post-randomization. |
Arm/Group Title | All Screened Subjects | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|---|
Arm/Group Description | After screening but prior to randomization, subjects completed a 4-week washout and a 4-week tadalafil [5-milligram (mg) tablet, administered orally, once daily] lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) |
Period Title: Screening, Washout, and Lead-In Period | ||||||
STARTED | 894 | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 410 | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 484 | 0 | 0 | 0 | 0 | 0 |
Period Title: Screening, Washout, and Lead-In Period | ||||||
STARTED | 0 | 85 | 97 | 52 | 89 | 87 |
Received at Least 1 Dose of Study Drug | 0 | 85 | 97 | 52 | 89 | 87 |
COMPLETED | 0 | 65 | 73 | 31 | 80 | 73 |
NOT COMPLETED | 0 | 20 | 24 | 21 | 9 | 14 |
Baseline Characteristics
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil | Total |
---|---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | Total of all reporting groups |
Overall Participants | 85 | 97 | 52 | 89 | 87 | 410 |
Age (years) [Mean (Standard Deviation) ] | ||||||
Mean (Standard Deviation) [years] |
59.7
(6.57)
|
60.7
(6.57)
|
58.7
(6.53)
|
59.4
(6.54)
|
60.5
(6.68)
|
59.9
(6.59)
|
Sex: Female, Male (Count of Participants) | ||||||
Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Male |
85
100%
|
97
100%
|
52
100%
|
89
100%
|
87
100%
|
410
100%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||||
Hispanic or Latino |
9
10.6%
|
13
13.4%
|
3
5.8%
|
13
14.6%
|
10
11.5%
|
48
11.7%
|
Not Hispanic or Latino |
76
89.4%
|
84
86.6%
|
49
94.2%
|
76
85.4%
|
77
88.5%
|
362
88.3%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | ||||||
American Indian or Alaska Native |
1
1.2%
|
2
2.1%
|
0
0%
|
2
2.2%
|
0
0%
|
5
1.2%
|
Asian |
2
2.4%
|
2
2.1%
|
0
0%
|
2
2.2%
|
0
0%
|
6
1.5%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
14
16.5%
|
17
17.5%
|
7
13.5%
|
13
14.6%
|
8
9.2%
|
59
14.4%
|
White |
68
80%
|
76
78.4%
|
45
86.5%
|
72
80.9%
|
78
89.7%
|
339
82.7%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.1%
|
1
0.2%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | ||||||
United States |
85
100%
|
97
100%
|
52
100%
|
89
100%
|
87
100%
|
410
100%
|
Outcome Measures
Title | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score |
---|---|
Description | The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized participants who received at least 1 dose of study drug [intention-to-treat (ITT) population] and had non-missing IIEF EF domain scores at baseline and at Week 12; Last observation carried forward (LOCF) applied to statistical analyses. |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 66 | 74 | 34 | 83 | 74 |
Mean (Standard Deviation) [units on a scale] |
2.515
(6.019)
|
2.405
(6.920)
|
-0.971
(6.699)
|
3.530
(5.640)
|
2.054
(4.800)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | Only the treatment effects of 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.5 |
Comments | The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04. | |
Method | ANCOVA | |
Comments | Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp*baseline IIEF, tx grp*testosterone level interactions. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | Only the treatment effects of the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.498 |
Comments | The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04. | |
Method | ANCOVA | |
Comments | The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp*baseline IIEF, tx grp*testosterone level interactions. |
Title | Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary |
---|---|
Description | The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value <0.25). |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing SEP diary data at baseline and at a post-baseline visit. |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 79 | 86 | 46 | 88 | 80 |
Question 1 |
-0.247
(2.378)
|
-2.976
(2.295)
|
-10.711
(3.268)
|
4.427
(2.168)
|
-1.425
(2.305)
|
Question 2 |
3.175
(3.345)
|
3.689
(3.227)
|
-7.849
(4.566)
|
10.267
(3.064)
|
1.844
(3.240)
|
Question 3 |
9.296
(3.808)
|
11.752
(3.675)
|
-3.800
(5.195)
|
14.645
(3.489)
|
2.593
(3.688)
|
Question 4 |
12.935
(3.998)
|
13.910
(3.854)
|
-1.570
(5.454)
|
24.202
(3.656)
|
8.857
(3.872)
|
Question 5 |
13.602
(4.027)
|
15.196
(3.880)
|
-1.956
(5.488)
|
22.410
(3.683)
|
9.400
(3.897)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.722 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 1.178 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.312 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.634 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -1.552 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.253 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.147 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -4.674 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.218 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.020 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -7.404 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.157 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.775 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 1.330 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.658 |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.687 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 1.844 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.573 |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.119 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -7.092 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.535 |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.140 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -6.578 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.450 |
|
Estimation Comments |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.207 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 6.703 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.302 |
|
Estimation Comments |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.079 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 9.159 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.206 |
|
Estimation Comments |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.301 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -5.349 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.165 |
|
Estimation Comments |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.568 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -2.893 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.067 |
|
Estimation Comments |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.464 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 4.079 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.566 |
|
Estimation Comments |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.356 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 5.054 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.463 |
|
Estimation Comments |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.038 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -11.266 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.418 |
|
Estimation Comments |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.054 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -10.292 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.312 |
|
Estimation Comments |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.454 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 4.202 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.603 |
|
Estimation Comments |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.293 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 5.796 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.499 |
|
Estimation Comments |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.107 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -8.808 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.457 |
|
Estimation Comments |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.178 |
Comments | The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -7.214 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.349 |
|
Estimation Comments |
Title | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) |
---|---|
Description | Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25). |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing IIEF domain scores at baseline and at a post-baseline visit. |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 80 | 88 | 48 | 88 | 81 |
Intercourse Satisfaction |
0.475
(0.340)
|
0.514
(0.322)
|
-0.672
(0.463)
|
1.127
(0.310)
|
0.554
(0.327)
|
Orgasmic Function |
0.510
(0.289)
|
0.117
(0.274)
|
0.160
(0.394)
|
0.678
(0.264)
|
0.733
(0.278)
|
Sexual Desire |
0.092
(0.186)
|
0.001
(0.176)
|
-0.201
(0.253)
|
0.392
(0.169)
|
0.180
(0.178)
|
Overall Satisfaction |
0.477
(0.247)
|
0.258
(0.235)
|
-0.378
(0.339)
|
1.206
(0.226)
|
0.826
(0.238)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.867 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.079 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.472 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.931 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.039 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.458 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.158 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.652 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.460 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.172 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.612 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.447 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.579 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.223 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.401 |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.115 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.616 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.390 |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.668 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.168 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.392 |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.141 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.561 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.380 |
|
Estimation Comments |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.734 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.088 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.258 |
|
Estimation Comments |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.477 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.179 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.251 |
|
Estimation Comments |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.235 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.300 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.252 |
|
Estimation Comments |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.111 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.391 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.245 |
|
Estimation Comments |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.310 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.349 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.343 |
|
Estimation Comments |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.090 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.568 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.334 |
|
Estimation Comments |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.030 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.729 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.335 |
|
Estimation Comments |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.004 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.948 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.326 |
|
Estimation Comments |
Title | Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25) |
---|---|
Description | The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to >25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized participants who received at least 1 dose of study drug (ITT population). |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 85 | 97 | 52 | 89 | 87 |
Number [percentage of participants] |
24.7
29.1%
|
27.8
28.7%
|
13.5
26%
|
30.3
34%
|
27.6
31.7%
|
Title | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups |
---|---|
Description | The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (<340 nanograms per deciliter [ng/dL] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline*treatment interaction (if p-value<0.25). |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing IIEF EF domain scores at baseline and at a post-baseline visit; Last observation carried forward (LOCF). |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 80 | 88 | 48 | 88 | 81 |
Testosterone <340 ng/dL |
2.523
(0.952)
|
1.012
(0.848)
|
-1.055
(1.223)
|
4.172
(0.852)
|
1.935
(0.912)
|
Testosterone ≥340 ng/dL |
1.077
(1.019)
|
3.416
(1.071)
|
-0.714
(1.387)
|
2.217
(1.070)
|
1.703
(1.063)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.656 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level <340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | ANCOVA | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.460 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level <340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | ANCOVA | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.198 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level <340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | ANCOVA | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.009 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | ANCOVA | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.671 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | ANCOVA | |
Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.259 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | ANCOVA | |
Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.441 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | ANCOVA | |
Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.433 |
Comments | The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | ANCOVA | |
Comments |
Title | Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) |
---|---|
Description | The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25). |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing PSA data at baseline and at a post-baseline visit. |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 81 | 89 | 49 | 87 | 82 |
Least Squares Mean (Standard Error) [nanograms per milliliter (ng/mL)] |
0.162
(0.119)
|
-0.088
(0.109)
|
0.265
(0.157)
|
0.246
(0.107)
|
0.032
(0.111)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.423 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 0.130 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.443 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.120 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.599 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.084 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.029 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.334 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides |
---|---|
Description | The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25). |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (total cholesterol and triglycerides) at baseline and at a post-baseline visit. |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 81 | 90 | 49 | 88 | 82 |
Total Cholesterol |
-0.210
(0.076)
|
-0.275
(0.071)
|
-0.282
(0.102)
|
-0.086
(0.069)
|
-0.059
(0.072)
|
Triglycerides |
-0.155
(0.070)
|
-0.171
(0.066)
|
-0.067
(0.096)
|
-0.139
(0.063)
|
0.056
(0.067)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.148 |
Comments | The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean of treatment difference |
Estimated Value | -0.152 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.033 |
Comments | The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.216 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.224 |
Comments | The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.124 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.056 |
Comments | The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.189 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.031 |
Comments | The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.211 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.017 |
Comments | The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.227 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.866 |
Comments | The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.016 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.726 |
Comments | The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.032 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) |
---|---|
Description | The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25). |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (HDL-C and LDL-C) at baseline and at a post-baseline visit. |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 81 | 90 | 49 | 88 | 82 |
HDL-C |
-7.440
(1.658)
|
-16.974
(1.556)
|
-22.230
(2.243)
|
1.776
(1.505)
|
1.573
(1.585)
|
LDL-C |
-1.695
(2.479)
|
0.062
(2.319)
|
-3.424
(3.365)
|
-0.066
(2.245)
|
-0.718
(2.367)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean of treatment difference |
Estimated Value | -9.014 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -18.547 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -9.216 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -18.750 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.776 |
Comments | The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.977 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.814 |
Comments | The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 0.780 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.627 |
Comments | The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -1.629 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.968 |
Comments | The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 0.128 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change From Baseline to 12 Week Endpoint in Fasting Glucose |
---|---|
Description | The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25). |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (fasting glucose) at baseline and at a post-baseline visit. |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 81 | 90 | 49 | 88 | 82 |
Least Squares Mean (Standard Error) [millimoles per Liter (mmol/L)] |
0.153
(0.195)
|
-0.306
(0.183)
|
0.070
(0.268)
|
-0.234
(0.176)
|
0.158
(0.186)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.984 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean of treatment difference |
Estimated Value | -0.006 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.076 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.465 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.142 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 0.387 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.776 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -0.072 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change From Baseline to 12 Week Endpoint in Fasting Insulin |
---|---|
Description | Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25). |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (fasting insulin) at baseline and at a post-baseline visit. |
Arm/Group Title | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil |
---|---|---|---|---|---|
Arm/Group Description | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. |
Measure Participants | 80 | 90 | 49 | 88 | 82 |
Least Squares Mean (Standard Error) [milliunits per Liter (mU/L)] |
3.756
(2.235)
|
-4.501
(2.075)
|
-0.717
(3.068)
|
-3.300
(1.976)
|
-1.276
(2.109)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.103 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean of treatment difference |
Estimated Value | 5.031 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.277 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean treatment difference |
Estimated Value | -3.225 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.019 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | 7.056 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.676 |
Comments | Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity. | |
Method | Mixed model repeated measures analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | LS mean of treatment difference |
Estimated Value | -1.201 | |
Confidence Interval |
() 95% to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||||
Arm/Group Title | 5 mg Tadalafil, Lead-in Period | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil | ||||||
Arm/Group Description | 5-mg tadalafil tablet, administered orally, once daily, during the 4-week lead-in period. | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 1-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule tadalafil 5-mg tablet placebo 10-mg tablet (matching tadalafil) | The following study drugs, administered orally, once daily for 12 weeks post-randomization: LY2452473 5-mg capsule placebo 5-mg tablet (matching tadalafil) placebo 10-mg tablet (matching tadalafil) | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 10-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 5-mg tablet (matching tadalafil) | The following study drugs, administered orally, once daily for 12 weeks post-randomization: tadalafil 5-mg tablet placebo 5-mg capsule (matching LY2452473) placebo 10-mg tablet (matching tadalafil) | ||||||
All Cause Mortality |
||||||||||||
5 mg Tadalafil, Lead-in Period | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil | |||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
5 mg Tadalafil, Lead-in Period | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil | |||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/531 (0.4%) | 2/85 (2.4%) | 1/97 (1%) | 1/52 (1.9%) | 0/89 (0%) | 0/87 (0%) | ||||||
Cardiac disorders | ||||||||||||
Arrhythmia | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Cardiac arrest | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Hypertensive cardiomyopathy | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Infections and infestations | ||||||||||||
Lobar pneumonia | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||||||
Humerus fracture | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Renal and urinary disorders | ||||||||||||
Tubulointerstitial nephritis | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||||
Pulmonary embolism | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
5 mg Tadalafil, Lead-in Period | 1 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 and 5 mg Tadalafil | 5 mg LY2452473 | 10 mg Tadalafil | 5 mg Tadalafil | |||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 88/531 (16.6%) | 27/85 (31.8%) | 23/97 (23.7%) | 10/52 (19.2%) | 34/89 (38.2%) | 33/87 (37.9%) | ||||||
Blood and lymphatic system disorders | ||||||||||||
Anaemia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Cardiac disorders | ||||||||||||
Arrhythmia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Bradycardia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Bundle branch block right | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Cardiomegaly | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Eye disorders | ||||||||||||
Corneal erosion | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Eye swelling | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Ocular hyperaemia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Vision blurred | 2/531 (0.4%) | 2 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Gastrointestinal disorders | ||||||||||||
Barrett's oesophagus | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Colonic polyp | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Constipation | 3/531 (0.6%) | 3 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Diarrhoea | 4/531 (0.8%) | 4 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Diverticulum | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Diverticulum intestinal | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Dyspepsia | 6/531 (1.1%) | 6 | 1/85 (1.2%) | 1 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 1/87 (1.1%) | 1 |
Gastrooesophageal reflux disease | 7/531 (1.3%) | 7 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 3/89 (3.4%) | 3 | 2/87 (2.3%) | 2 |
Hiatus hernia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Inguinal hernia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Nausea | 2/531 (0.4%) | 2 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Oesophagitis | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
General disorders | ||||||||||||
Chest discomfort | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Chest pain | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Fatigue | 4/531 (0.8%) | 4 | 0/85 (0%) | 0 | 2/97 (2.1%) | 2 | 0/52 (0%) | 0 | 2/89 (2.2%) | 2 | 1/87 (1.1%) | 1 |
Irritability | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Oedema peripheral | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Pain | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Pyrexia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Immune system disorders | ||||||||||||
Seasonal allergy | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Infections and infestations | ||||||||||||
Bronchitis | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Candidiasis | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Ear infection | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 2/89 (2.2%) | 2 | 0/87 (0%) | 0 |
Herpes zoster | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Influenza | 1/531 (0.2%) | 1 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Nail infection | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Nasopharyngitis | 5/531 (0.9%) | 5 | 3/85 (3.5%) | 3 | 1/97 (1%) | 1 | 1/52 (1.9%) | 1 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Oral herpes | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 2 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Pharyngitis streptococcal | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Pneumonia | 0/531 (0%) | 0 | 2/85 (2.4%) | 2 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Rhinitis | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Sinusitis | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 1/87 (1.1%) | 1 |
Subcutaneous abscess | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Tinea infection | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Tonsillitis | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Tooth abscess | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Upper respiratory tract infection | 2/531 (0.4%) | 2 | 1/85 (1.2%) | 1 | 2/97 (2.1%) | 2 | 0/52 (0%) | 0 | 4/89 (4.5%) | 4 | 3/87 (3.4%) | 3 |
Urinary tract infection | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 2/52 (3.8%) | 2 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Wound infection | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||||||
Contusion | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Corneal abrasion | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Excoriation | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 2 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Laceration | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Ligament sprain | 2/531 (0.4%) | 2 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 2/87 (2.3%) | 2 |
Limb injury | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Muscle rupture | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Muscle strain | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 2/89 (2.2%) | 2 | 1/87 (1.1%) | 1 |
Radius fracture | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Rib fracture | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Sunburn | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Investigations | ||||||||||||
Aspartate aminotransferase increased | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 2/87 (2.3%) | 2 |
Blood creatine phosphokinase abnormal | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Blood creatine phosphokinase increased | 2/531 (0.4%) | 2 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 2/87 (2.3%) | 2 |
Blood creatinine abnormal | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Blood creatinine increased | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 2/89 (2.2%) | 2 | 0/87 (0%) | 0 |
Blood glucose increased | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Blood insulin increased | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Blood testosterone abnormal | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Blood urea abnormal | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Blood urea increased | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
C-reactive protein increased | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Colonoscopy | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Electrocardiogram qrs complex prolonged | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
High density lipoprotein decreased | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Oestradiol increased | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Prostatic specific antigen increased | 1/531 (0.2%) | 1 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Qrs axis abnormal | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Weight decreased | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Weight increased | 1/531 (0.2%) | 1 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||||||
Gout | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Hyperlipidaemia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Vitamin d deficiency | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||||
Arthralgia | 1/531 (0.2%) | 1 | 1/85 (1.2%) | 1 | 2/97 (2.1%) | 2 | 1/52 (1.9%) | 1 | 3/89 (3.4%) | 3 | 0/87 (0%) | 0 |
Arthritis | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Back pain | 4/531 (0.8%) | 4 | 3/85 (3.5%) | 3 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 3/89 (3.4%) | 3 | 1/87 (1.1%) | 1 |
Flank pain | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Muscle spasms | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Musculoskeletal pain | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 1/89 (1.1%) | 1 | 1/87 (1.1%) | 1 |
Myalgia | 3/531 (0.6%) | 3 | 2/85 (2.4%) | 3 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Osteopenia | 3/531 (0.6%) | 4 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 0/89 (0%) | 0 | 2/87 (2.3%) | 2 |
Osteoporosis | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 2/87 (2.3%) | 2 |
Pain in extremity | 4/531 (0.8%) | 4 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Sensation of heaviness | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Spinal disorder | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Tendonitis | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
Malignant melanoma | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Squamous cell carcinoma of skin | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Nervous system disorders | ||||||||||||
Burning sensation | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Dizziness | 3/531 (0.6%) | 3 | 2/85 (2.4%) | 3 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 2/89 (2.2%) | 2 | 0/87 (0%) | 0 |
Headache | 9/531 (1.7%) | 9 | 3/85 (3.5%) | 3 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 3/89 (3.4%) | 3 | 2/87 (2.3%) | 2 |
Hypoaesthesia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Lethargy | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Sinus headache | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Renal and urinary disorders | ||||||||||||
Dysuria | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Haematuria | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Nephrolithiasis | 2/531 (0.4%) | 2 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Renal failure | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Renal failure acute | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Reproductive system and breast disorders | ||||||||||||
Epididymitis | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Haematospermia | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 2/87 (2.3%) | 2 |
Prostatitis | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Varicocele | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||||
Asthma | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Bronchial hyperreactivity | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Cough | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Dyspnoea | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Dyspnoea exertional | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Nasal congestion | 3/531 (0.6%) | 3 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 2/89 (2.2%) | 2 | 2/87 (2.3%) | 2 |
Obstructive airways disorder | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Oropharyngeal pain | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Paranasal sinus hypersecretion | 2/531 (0.4%) | 2 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Rhinitis allergic | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Sinus congestion | 1/531 (0.2%) | 1 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 2/89 (2.2%) | 2 | 0/87 (0%) | 0 |
Sinus disorder | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 1/52 (1.9%) | 1 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Throat irritation | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||||||
Dermatitis | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Dermatitis contact | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Diabetic bullosis | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Rash | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 2/97 (2.1%) | 2 | 0/52 (0%) | 0 | 2/89 (2.2%) | 2 | 0/87 (0%) | 0 |
Skin lesion | 1/531 (0.2%) | 1 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Surgical and medical procedures | ||||||||||||
Tooth extraction | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 0/87 (0%) | 0 |
Vascular disorders | ||||||||||||
Flushing | 1/531 (0.2%) | 1 | 1/85 (1.2%) | 1 | 1/97 (1%) | 1 | 0/52 (0%) | 0 | 1/89 (1.1%) | 1 | 1/87 (1.1%) | 1 |
Haematoma | 0/531 (0%) | 0 | 1/85 (1.2%) | 1 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 0/87 (0%) | 0 |
Hypotension | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Spider vein | 0/531 (0%) | 0 | 0/85 (0%) | 0 | 0/97 (0%) | 0 | 0/52 (0%) | 0 | 0/89 (0%) | 0 | 1/87 (1.1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Eli Lilly and Company |
Phone | 800-545-5979 |
- 11888
- I4K-MC-GPEC