Trial Outcomes & Findings for A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China (NCT NCT01352507)
NCT ID: NCT01352507
Last Updated: 2013-04-26
Results Overview
PITPQ Question (Q) 1 was a dichotomous outcome measure in which the participant selected his preferred study treatment (tadalafil or sildenafil) to receive during the Extension Phase.
COMPLETED
PHASE4
383 participants
Week 18
2013-04-26
Participant Flow
Participant milestones
| Measure |
Tadalafil Then Sildenafil
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).
|
Sildenafil Then Tadalafil
100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
190
|
193
|
|
Treatment Period 1
Received Treatment
|
182
|
188
|
|
Treatment Period 1
COMPLETED
|
176
|
184
|
|
Treatment Period 1
NOT COMPLETED
|
14
|
9
|
|
Washout Period
STARTED
|
176
|
184
|
|
Washout Period
COMPLETED
|
176
|
183
|
|
Washout Period
NOT COMPLETED
|
0
|
1
|
|
Treatment Period 2
STARTED
|
176
|
183
|
|
Treatment Period 2
Received Treatment
|
173
|
181
|
|
Treatment Period 2
COMPLETED
|
170
|
180
|
|
Treatment Period 2
NOT COMPLETED
|
6
|
3
|
|
Extension Phase
STARTED
|
164
|
173
|
|
Extension Phase
COMPLETED
|
164
|
173
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tadalafil Then Sildenafil
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).
|
Sildenafil Then Tadalafil
100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED.
|
|---|---|---|
|
Treatment Period 1
Adverse Event
|
3
|
0
|
|
Treatment Period 1
Lost to Follow-up
|
3
|
4
|
|
Treatment Period 1
Withdrawal by Subject
|
7
|
5
|
|
Treatment Period 1
Physician Decision
|
1
|
0
|
|
Washout Period
Withdrawal by Subject
|
0
|
1
|
|
Treatment Period 2
Entry Criteria Not Met
|
1
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
4
|
3
|
|
Treatment Period 2
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China
Baseline characteristics by cohort
| Measure |
Tadalafil Then Sildenafil
n=190 Participants
20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).
|
Sildenafil Then Tadalafil
n=193 Participants
100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.
At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED.
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
39.20 years
STANDARD_DEVIATION 10.52 • n=99 Participants
|
40.66 years
STANDARD_DEVIATION 11.44 • n=107 Participants
|
39.94 years
STANDARD_DEVIATION 11.00 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
190 Participants
n=99 Participants
|
193 Participants
n=107 Participants
|
383 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
190 participants
n=99 Participants
|
193 participants
n=107 Participants
|
383 participants
n=206 Participants
|
|
Region of Enrollment
China
|
190 participants
n=99 Participants
|
193 participants
n=107 Participants
|
383 participants
n=206 Participants
|
|
International Index of Erectile Function (IIEF) Erectile Function (EF) Domain
|
13.77 units on a scale
STANDARD_DEVIATION 5.37 • n=99 Participants
|
14.19 units on a scale
STANDARD_DEVIATION 6.08 • n=107 Participants
|
13.98 units on a scale
STANDARD_DEVIATION 5.73 • n=206 Participants
|
|
Erectile Dysfunction (ED) Severity
Mild
|
63 participants
n=99 Participants
|
68 participants
n=107 Participants
|
131 participants
n=206 Participants
|
|
Erectile Dysfunction (ED) Severity
Moderate
|
68 participants
n=99 Participants
|
65 participants
n=107 Participants
|
133 participants
n=206 Participants
|
|
Erectile Dysfunction (ED) Severity
Severe
|
59 participants
n=99 Participants
|
60 participants
n=107 Participants
|
119 participants
n=206 Participants
|
|
ED Duration
≥3 months to <1 year
|
77 participants
n=99 Participants
|
87 participants
n=107 Participants
|
164 participants
n=206 Participants
|
|
ED Duration
≥1 year
|
113 participants
n=99 Participants
|
106 participants
n=107 Participants
|
219 participants
n=206 Participants
|
|
ED Etiology
Psychogenic
|
46 participants
n=99 Participants
|
41 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
ED Etiology
Organic
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
ED Etiology
Mixed
|
133 participants
n=99 Participants
|
139 participants
n=107 Participants
|
272 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 18Population: Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.
PITPQ Question (Q) 1 was a dichotomous outcome measure in which the participant selected his preferred study treatment (tadalafil or sildenafil) to receive during the Extension Phase.
Outcome measures
| Measure |
All Randomized Participants
n=350 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Percentage of Participants Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the "Phosphodiesterase 5 Inhibitor Treatment Preference" Questionnaire (PITPQ)
|
69.1 percentage of participants
Interval 64.0 to 74.0
|
—
|
SECONDARY outcome
Timeframe: Week 18Population: Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.
PITPQ Q2 was a measure of the degree of treatment preference based on the participant's opinion. The question was, "For the treatment preference you selected in Q1, what is your degree of preference?". Choices were moderate or strong.
Outcome measures
| Measure |
All Randomized Participants
n=242 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=108 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ
Strong preference
|
38.0 percentage of participants
|
34.3 percentage of participants
|
|
Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ
Moderate preference
|
62.0 percentage of participants
|
65.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: All randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Self-reported overall satisfaction over the past 4 weeks. IIEF overall satisfaction was the sum of Q13 and Q14. Scores ranged from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF overall satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF overall satisfaction domain score. Higher IIEF overall satisfaction domain scores were indicative of greater overall satisfaction.
Outcome measures
| Measure |
All Randomized Participants
n=355 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain
|
3.74 units on a scale
Standard Deviation 1.94
|
3.71 units on a scale
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: Randomized participants with baseline and at least 1 post-baseline SEP measurement.
Participant-assessed diary that assessed the mean change from baseline in the percentage of "yes" responses to SEP Q2, "Were you able to insert your penis into your partner's vagina?". The SEP Q2 score was determined as the percentage of "yes" responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus the percentage of "yes" responses at baseline. Change in percentage of "yes" responses to SEP Q2 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q2.
Outcome measures
| Measure |
All Randomized Participants
n=356 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in Sexual Encounter Profile (SEP) Question 2
|
45.28 percentage of "yes" responses
Standard Deviation 42.03
|
44.94 percentage of "yes" responses
Standard Deviation 41.62
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.
PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The sexual self-confidence domain score was the average score for Items 5, 10, 15, 23, 27, and 29. Sexual self-confidence domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS sexual self-confidence domain scores at Week 8 and Week 18 were averaged to produce an overall change in PAIRS sexual self-confidence domain score. Higher scores were indicative of greater sexual self-confidence.
Outcome measures
| Measure |
All Randomized Participants
n=355 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain
|
0.75 units on a scale
Standard Deviation 0.65
|
0.72 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Week 18Population: Randomized participants who completed both treatment periods (Week 18), responded to the DRAQ, and were analyzed according to their assigned treatment.
DRAQ was a questionnaire used to record explanations for why participants preferred a drug. Participants identified their first and second reasons for drug preference from a choice of 7 reasons. Each reason for drug preference includes participants who selected that reason as their first or second reason.
Outcome measures
| Measure |
All Randomized Participants
n=242 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=108 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Drug Attributes Questionnaire (DRAQ) at Week 18
Time between drug and first erection was short
|
10.3 percentage of participants
|
35.2 percentage of participants
|
|
Drug Attributes Questionnaire (DRAQ) at Week 18
Was able to get an erection long after having drug
|
55.0 percentage of participants
|
11.1 percentage of participants
|
|
Drug Attributes Questionnaire (DRAQ) at Week 18
Had erections the next morning
|
24.0 percentage of participants
|
11.1 percentage of participants
|
|
Drug Attributes Questionnaire (DRAQ) at Week 18
The firmness of erections
|
36.4 percentage of participants
|
51.9 percentage of participants
|
|
Drug Attributes Questionnaire (DRAQ) at Week 18
Was able to get an erection every time
|
37.6 percentage of participants
|
56.5 percentage of participants
|
|
Drug Attributes Questionnaire (DRAQ) at Week 18
Had few side effects
|
23.6 percentage of participants
|
25.9 percentage of participants
|
|
Drug Attributes Questionnaire (DRAQ) at Week 18
Partner preferred this treatment
|
10.7 percentage of participants
|
7.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: All randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Self-reported intercourse satisfaction over the past 4 weeks. IIEF intercourse satisfaction was the sum of Q6, Q7, and Q8 of the IIEF. Scores ranged from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15. Change was defined as endpoint minus baseline domain score. Change in IIEF intercourse satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF intercourse satisfaction domain score. Higher scores were indicative of an increase in intercourse satisfaction.
Outcome measures
| Measure |
All Randomized Participants
n=355 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain
|
5.88 units on a scale
Standard Deviation 3.02
|
5.91 units on a scale
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: Randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Self-reported sexual desire over the past 4 weeks. IIEF sexual desire was the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF sexual desire domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF sexual desire domain score. Higher scores were indicative of increased sexual desire.
Outcome measures
| Measure |
All Randomized Participants
n=355 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) Sexual Desire Domain
|
2.55 units on a scale
Standard Deviation 2.11
|
2.60 units on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: Randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Self-reported orgasmic function over the past 4 weeks. IIEF orgasmic function was the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF orgasmic function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF orgasmic function domain score. Higher scores were indicative of better orgasmic function.
Outcome measures
| Measure |
All Randomized Participants
n=355 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain
|
3.70 units on a scale
Standard Deviation 2.82
|
3.71 units on a scale
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: Randomized participants with baseline and at least 1 SEP post-baseline measurement.
Participant-assessed diary that assessed the mean change from baseline in the percentage of "yes" responses to SEP Q3, "Did your erection last long enough for you to have successful intercourse?". The SEP Q3 score was determined as the percentage of "yes" responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus percentage of "yes" responses at baseline. Change in the percentage of "yes" responses to SEP Q3 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q3.
Outcome measures
| Measure |
All Randomized Participants
n=356 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in Sexual Encounter Profile (SEP) Question 3
|
64.53 percentage of "yes" responses
Standard Deviation 38.37
|
63.72 percentage of "yes" responses
Standard Deviation 37.66
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.
PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The spontaneity domain score was the average score for Items 3, 12, 13, 16, 17, 19, 21, 22, and 28. Spontaneity domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS spontaneity domain at Week 8 and Week 18 were averaged to produce an overall change in PAIRS spontaneity domain score. Higher scores were indicative of greater spontaneity.
Outcome measures
| Measure |
All Randomized Participants
n=355 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in PAIRS Spontaneity Domain
|
0.33 units on a scale
Standard Deviation 0.53
|
0.20 units on a scale
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.
PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The time concerns domain score was the average score for Items 1, 2, 6, 7, 8, 20, 24, and 25. Time concern domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS time concerns at Week 8 and Week 18 were averaged to produce an overall change in PAIRS time concerns domain score. Higher scores were indicative of more time concerns.
Outcome measures
| Measure |
All Randomized Participants
n=355 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in PAIRS Time Concerns Domain
|
-0.28 units on a scale
Standard Deviation 0.54
|
-0.14 units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and Week 18Population: Randomized participants with baseline and at least 1 IIEF post-baseline measurement.
Self-reported erectile function over the past 4 weeks. IIEF erectile function was the sum of Q1 through Q5 and Q15 of the IIEF. Q1 through Q5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Q15 was scored 1 (no/low confidence) to 5 (high confidence). IIEF erectile function domain scores ranged from 1 to 30. Change was defined as endpoint minus baseline domain score. Change in IIEF erectile function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF EF domain score. Higher scores were indicative of better erectile function.
Outcome measures
| Measure |
All Randomized Participants
n=355 Participants
Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
|
Sildenafil
n=354 Participants
Participants who preferred sildenafil over tadalafil.
|
|---|---|---|
|
Change in International Index of Erectile Function (IIEF) Erectile Function Domain
|
12.03 units on a scale
Standard Deviation 6.75
|
11.86 units on a scale
Standard Deviation 6.68
|
Adverse Events
Tadalafil (Treatment Periods)
Sildenafil (Treatment Periods)
Tadalafil (Extension Phase)
Sildenafil (Extension Phase)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tadalafil (Treatment Periods)
n=363 participants at risk
20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
|
Sildenafil (Treatment Periods)
n=361 participants at risk
100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
|
Tadalafil (Extension Phase)
n=231 participants at risk
Participants who preferred tadalafil over sildenafil received 20 mg tadalafil taken orally, as needed, for an additional 8 weeks.
|
Sildenafil (Extension Phase)
n=106 participants at risk
Participants who preferred sildenafil over tadalafil received 100 mg sildenafil taken orally, as needed, for an additional 8 weeks.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/363
|
0.00%
0/361
|
0.43%
1/231 • Number of events 1
|
0.00%
0/106
|
|
Nervous system disorders
Dizziness
|
1.7%
6/363 • Number of events 7
|
0.83%
3/361 • Number of events 3
|
0.87%
2/231 • Number of events 4
|
0.00%
0/106
|
|
Nervous system disorders
Headache
|
2.8%
10/363 • Number of events 13
|
1.4%
5/361 • Number of events 5
|
0.87%
2/231 • Number of events 4
|
0.00%
0/106
|
|
Cardiac disorders
Palpitations
|
0.28%
1/363 • Number of events 1
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Ear and labyrinth disorders
Deafness
|
0.28%
1/363 • Number of events 1
|
0.00%
0/361
|
0.00%
0/231
|
0.00%
0/106
|
|
Ear and labyrinth disorders
Vertigo
|
0.28%
1/363 • Number of events 1
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Eye disorders
Eye pain
|
0.55%
2/363 • Number of events 2
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Eye disorders
Eye swelling
|
0.83%
3/363 • Number of events 3
|
0.00%
0/361
|
0.43%
1/231 • Number of events 1
|
0.00%
0/106
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/363
|
0.55%
2/361 • Number of events 2
|
0.00%
0/231
|
0.00%
0/106
|
|
Eye disorders
Vision blurred
|
0.28%
1/363 • Number of events 1
|
0.28%
1/361 • Number of events 1
|
0.43%
1/231 • Number of events 1
|
0.00%
0/106
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/363
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Gastrointestinal disorders
Abdominal distension
|
0.28%
1/363 • Number of events 1
|
0.00%
0/361
|
0.00%
0/231
|
0.00%
0/106
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/363
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Gastrointestinal disorders
Dyspepsia
|
0.28%
1/363 • Number of events 1
|
0.55%
2/361 • Number of events 2
|
0.00%
0/231
|
0.00%
0/106
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.28%
1/363 • Number of events 1
|
0.00%
0/361
|
0.00%
0/231
|
0.00%
0/106
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/363
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Gastrointestinal disorders
Nausea
|
0.28%
1/363 • Number of events 1
|
0.55%
2/361 • Number of events 3
|
0.43%
1/231 • Number of events 1
|
0.00%
0/106
|
|
General disorders
Face oedema
|
0.28%
1/363 • Number of events 1
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.94%
1/106 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/363
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
General disorders
Pyrexia
|
0.00%
0/363
|
0.55%
2/361 • Number of events 2
|
0.00%
0/231
|
0.00%
0/106
|
|
General disorders
Thirst
|
0.28%
1/363 • Number of events 1
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Investigations
Alanine aminotransferase increased
|
0.28%
1/363 • Number of events 1
|
0.00%
0/361
|
0.00%
0/231
|
0.00%
0/106
|
|
Investigations
Aspartate aminotransferase increased
|
0.28%
1/363 • Number of events 1
|
0.00%
0/361
|
0.00%
0/231
|
0.00%
0/106
|
|
Investigations
Body temperature increased
|
0.00%
0/363
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.28%
1/363 • Number of events 1
|
0.28%
1/361 • Number of events 1
|
0.43%
1/231 • Number of events 1
|
0.00%
0/106
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.55%
2/363 • Number of events 2
|
0.55%
2/361 • Number of events 2
|
0.00%
0/231
|
0.00%
0/106
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.28%
1/363 • Number of events 2
|
0.00%
0/361
|
0.00%
0/231
|
0.00%
0/106
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/363
|
0.00%
0/361
|
0.43%
1/231 • Number of events 1
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.28%
1/363 • Number of events 1
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.83%
3/363 • Number of events 4
|
0.83%
3/361 • Number of events 3
|
0.43%
1/231 • Number of events 1
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.28%
1/363 • Number of events 1
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.28%
1/363 • Number of events 1
|
0.00%
0/361
|
0.00%
0/231
|
0.00%
0/106
|
|
Vascular disorders
Flushing
|
0.55%
2/363 • Number of events 2
|
1.7%
6/361 • Number of events 7
|
0.00%
0/231
|
0.94%
1/106 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.28%
1/363 • Number of events 1
|
0.00%
0/361
|
0.00%
0/231
|
0.00%
0/106
|
|
Vascular disorders
Varicose vein
|
0.00%
0/363
|
0.28%
1/361 • Number of events 1
|
0.00%
0/231
|
0.00%
0/106
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60