Trial Outcomes & Findings for A Study of LY2623091 in Participants With High Blood Pressure (NCT NCT02194465)
NCT ID: NCT02194465
Last Updated: 2020-06-26
Results Overview
Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
304 participants
Primary outcome timeframe
Baseline, 4 Weeks
Results posted on
2020-06-26
Participant Flow
Participants entered at lead-in for wash out and a placebo run-in period prior to randomization.
Participant milestones
| Measure |
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
|
6 Milligrams (mg) LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
52
|
49
|
51
|
25
|
26
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
51
|
50
|
51
|
49
|
51
|
25
|
26
|
|
Overall Study
COMPLETED
|
42
|
43
|
44
|
41
|
42
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
8
|
8
|
9
|
4
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo for blinding administered orally once daily for 4 weeks.
|
6 Milligrams (mg) LY2623091
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
4
|
4
|
4
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
1
|
2
|
2
|
1
|
2
|
|
Overall Study
Discontinued follow-up period
|
0
|
2
|
1
|
0
|
2
|
0
|
0
|
Baseline Characteristics
All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Placebo for blinding administered orally once daily for 4 weeks.
|
6 mg LY2623091
n=50 Participants
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
n=51 Participants
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
n=49 Participants
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
n=51 Participants
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
n=25 Participants
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
n=26 Participants
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 9.4 • n=51 Participants
|
56.6 years
STANDARD_DEVIATION 11.4 • n=50 Participants
|
58.0 years
STANDARD_DEVIATION 8.8 • n=51 Participants
|
58.7 years
STANDARD_DEVIATION 8.8 • n=49 Participants
|
57.9 years
STANDARD_DEVIATION 9.5 • n=51 Participants
|
54.0 years
STANDARD_DEVIATION 8.9 • n=25 Participants
|
59.0 years
STANDARD_DEVIATION 11.0 • n=26 Participants
|
57.7 years
STANDARD_DEVIATION 9.7 • n=303 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=51 Participants
|
17 Participants
n=50 Participants
|
24 Participants
n=51 Participants
|
20 Participants
n=49 Participants
|
21 Participants
n=51 Participants
|
8 Participants
n=25 Participants
|
7 Participants
n=26 Participants
|
113 Participants
n=303 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=51 Participants
|
33 Participants
n=50 Participants
|
27 Participants
n=51 Participants
|
29 Participants
n=49 Participants
|
30 Participants
n=51 Participants
|
17 Participants
n=25 Participants
|
19 Participants
n=26 Participants
|
190 Participants
n=303 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=51 Participants
|
5 Participants
n=50 Participants
|
2 Participants
n=51 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=51 Participants
|
4 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
20 Participants
n=303 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=51 Participants
|
39 Participants
n=50 Participants
|
45 Participants
n=51 Participants
|
39 Participants
n=49 Participants
|
43 Participants
n=51 Participants
|
19 Participants
n=25 Participants
|
23 Participants
n=26 Participants
|
250 Participants
n=303 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=51 Participants
|
6 Participants
n=50 Participants
|
4 Participants
n=51 Participants
|
8 Participants
n=49 Participants
|
4 Participants
n=51 Participants
|
2 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
33 Participants
n=303 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=49 Participants
|
1 Participants
n=51 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
5 Participants
n=303 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=51 Participants
|
4 Participants
n=50 Participants
|
2 Participants
n=51 Participants
|
6 Participants
n=49 Participants
|
2 Participants
n=51 Participants
|
2 Participants
n=25 Participants
|
3 Participants
n=26 Participants
|
26 Participants
n=303 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=303 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=51 Participants
|
15 Participants
n=50 Participants
|
14 Participants
n=51 Participants
|
12 Participants
n=49 Participants
|
13 Participants
n=51 Participants
|
7 Participants
n=25 Participants
|
6 Participants
n=26 Participants
|
80 Participants
n=303 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=51 Participants
|
30 Participants
n=50 Participants
|
34 Participants
n=51 Participants
|
29 Participants
n=49 Participants
|
35 Participants
n=51 Participants
|
15 Participants
n=25 Participants
|
16 Participants
n=26 Participants
|
187 Participants
n=303 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=51 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
5 Participants
n=303 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=303 Participants
|
|
Region of Enrollment
Canada
|
18 Participants
n=51 Participants
|
12 Participants
n=50 Participants
|
9 Participants
n=51 Participants
|
13 Participants
n=49 Participants
|
13 Participants
n=51 Participants
|
5 Participants
n=25 Participants
|
4 Participants
n=26 Participants
|
74 Participants
n=303 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=51 Participants
|
36 Participants
n=50 Participants
|
41 Participants
n=51 Participants
|
35 Participants
n=49 Participants
|
38 Participants
n=51 Participants
|
19 Participants
n=25 Participants
|
21 Participants
n=26 Participants
|
222 Participants
n=303 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 Participants
n=51 Participants
|
2 Participants
n=50 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
7 Participants
n=303 Participants
|
|
BMI
|
30.5 kilogram/square meter (kg/m2)
STANDARD_DEVIATION 4.5 • n=51 Participants
|
30.2 kilogram/square meter (kg/m2)
STANDARD_DEVIATION 5.2 • n=50 Participants
|
30.2 kilogram/square meter (kg/m2)
STANDARD_DEVIATION 4.9 • n=51 Participants
|
32.7 kilogram/square meter (kg/m2)
STANDARD_DEVIATION 4.5 • n=49 Participants
|
29.5 kilogram/square meter (kg/m2)
STANDARD_DEVIATION 4.7 • n=51 Participants
|
29.6 kilogram/square meter (kg/m2)
STANDARD_DEVIATION 4.2 • n=25 Participants
|
31.4 kilogram/square meter (kg/m2)
STANDARD_DEVIATION 4.5 • n=26 Participants
|
30.6 kilogram/square meter (kg/m2)
STANDARD_DEVIATION 4.8 • n=303 Participants
|
|
Chronic Kidney Disease (CKD)
Y
|
0 Participants
n=51 Participants
|
3 Participants
n=50 Participants
|
2 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
2 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
9 Participants
n=303 Participants
|
|
Chronic Kidney Disease (CKD)
N
|
51 Participants
n=51 Participants
|
47 Participants
n=50 Participants
|
49 Participants
n=51 Participants
|
49 Participants
n=49 Participants
|
51 Participants
n=51 Participants
|
23 Participants
n=25 Participants
|
24 Participants
n=26 Participants
|
294 Participants
n=303 Participants
|
|
Anti-Hypertensive Medication
0
|
8 Participants
n=51 Participants
|
10 Participants
n=50 Participants
|
5 Participants
n=51 Participants
|
7 Participants
n=49 Participants
|
13 Participants
n=51 Participants
|
6 Participants
n=25 Participants
|
3 Participants
n=26 Participants
|
52 Participants
n=303 Participants
|
|
Anti-Hypertensive Medication
1
|
24 Participants
n=51 Participants
|
22 Participants
n=50 Participants
|
25 Participants
n=51 Participants
|
22 Participants
n=49 Participants
|
17 Participants
n=51 Participants
|
10 Participants
n=25 Participants
|
10 Participants
n=26 Participants
|
130 Participants
n=303 Participants
|
|
Anti-Hypertensive Medication
2
|
19 Participants
n=51 Participants
|
17 Participants
n=50 Participants
|
20 Participants
n=51 Participants
|
19 Participants
n=49 Participants
|
20 Participants
n=51 Participants
|
8 Participants
n=25 Participants
|
13 Participants
n=26 Participants
|
116 Participants
n=303 Participants
|
|
Anti-Hypertensive Medication
3
|
0 Participants
n=51 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=51 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
4 Participants
n=303 Participants
|
|
Anti-Hypertensive Medication
4
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=303 Participants
|
|
Diabetes
Y
|
10 Participants
n=51 Participants
|
6 Participants
n=50 Participants
|
11 Participants
n=51 Participants
|
9 Participants
n=49 Participants
|
5 Participants
n=51 Participants
|
6 Participants
n=25 Participants
|
4 Participants
n=26 Participants
|
51 Participants
n=303 Participants
|
|
Diabetes
N
|
41 Participants
n=51 Participants
|
44 Participants
n=50 Participants
|
40 Participants
n=51 Participants
|
40 Participants
n=49 Participants
|
46 Participants
n=51 Participants
|
19 Participants
n=25 Participants
|
22 Participants
n=26 Participants
|
252 Participants
n=303 Participants
|
|
Baseline in Seated Systolic Blood Pressure (SBP)
|
151.2 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.8 • n=51 Participants
|
150.8 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.6 • n=50 Participants
|
153.7 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.3 • n=51 Participants
|
150.7 millimeter of mercury (mmHg)
STANDARD_DEVIATION 10.2 • n=49 Participants
|
152.1 millimeter of mercury (mmHg)
STANDARD_DEVIATION 9.6 • n=51 Participants
|
151.7 millimeter of mercury (mmHg)
STANDARD_DEVIATION 9.6 • n=25 Participants
|
153.4 millimeter of mercury (mmHg)
STANDARD_DEVIATION 9.0 • n=26 Participants
|
151.9 millimeter of mercury (mmHg)
STANDARD_DEVIATION 9.1 • n=303 Participants
|
|
Baseline in Seated Diastolic Blood Pressure (DBP)
|
89.8 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.8 • n=51 Participants • All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
|
88.2 millimeter of mercury (mmHg)
STANDARD_DEVIATION 9.7 • n=49 Participants • All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
|
90.5 millimeter of mercury (mmHg)
STANDARD_DEVIATION 9.5 • n=51 Participants • All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
|
88.5 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.5 • n=49 Participants • All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
|
90.6 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.9 • n=51 Participants • All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
|
91.5 millimeter of mercury (mmHg)
STANDARD_DEVIATION 8.8 • n=24 Participants • All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
|
88.6 millimeter of mercury (mmHg)
STANDARD_DEVIATION 11.6 • n=25 Participants • All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
|
89.6 millimeter of mercury (mmHg)
STANDARD_DEVIATION 9.3 • n=300 Participants • All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.
|
PRIMARY outcome
Timeframe: Baseline, 4 WeeksPopulation: All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for SBP.
Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo for blinding administered orally once daily for 4 weeks.
|
6 mg LY2623091
n=45 Participants
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
n=43 Participants
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
n=41 Participants
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
n=43 Participants
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
n=21 Participants
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
n=23 Participants
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)
|
-0.5 millimeter of mercury (mmHg)
Standard Error 11.6
|
-13.1 millimeter of mercury (mmHg)
Standard Error 11.2
|
-14.6 millimeter of mercury (mmHg)
Standard Error 12.3
|
-14.3 millimeter of mercury (mmHg)
Standard Error 13.6
|
-11.8 millimeter of mercury (mmHg)
Standard Error 12.5
|
-7.1 millimeter of mercury (mmHg)
Standard Error 13.3
|
-15.4 millimeter of mercury (mmHg)
Standard Error 11.7
|
SECONDARY outcome
Timeframe: Baseline, 4 WeeksPopulation: All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for DBP.
Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo for blinding administered orally once daily for 4 weeks.
|
6 mg LY2623091
n=45 Participants
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
n=43 Participants
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
n=41 Participants
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
n=43 Participants
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
n=21 Participants
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
n=23 Participants
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
|
0.5 mmHg
Standard Error 7.9
|
-5.6 mmHg
Standard Error 9.2
|
-4.8 mmHg
Standard Error 7.2
|
-7.1 mmHg
Standard Error 7.6
|
-6.8 mmHg
Standard Error 8.7
|
-6.6 mmHg
Standard Error 8.7
|
-1.2 mmHg
Standard Error 6.1
|
SECONDARY outcome
Timeframe: Baseline, 4 WeeksPopulation: All randomized participants receiving at least 1 dose of the study drug and had evaluable data for 24 hour ABPM.
The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo for blinding administered orally once daily for 4 weeks.
|
6 mg LY2623091
n=37 Participants
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
n=39 Participants
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
n=33 Participants
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
n=36 Participants
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
n=19 Participants
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
n=22 Participants
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
SBP
|
0.3 mmHg
Standard Error 11.3
|
-4.9 mmHg
Standard Error 8.7
|
-11.1 mmHg
Standard Error 8.9
|
-10.4 mmHg
Standard Error 11.4
|
-10.4 mmHg
Standard Error 11.6
|
-6.3 mmHg
Standard Error 8.9
|
-6.4 mmHg
Standard Error 6.8
|
|
Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
DBP
|
1.0 mmHg
Standard Error 7.7
|
-1.7 mmHg
Standard Error 6.3
|
-4.7 mmHg
Standard Error 6.1
|
-3.4 mmHg
Standard Error 4.8
|
-6.2 mmHg
Standard Error 8.0
|
-5.6 mmHg
Standard Error 4.9
|
-2.0 mmHg
Standard Error 4.6
|
SECONDARY outcome
Timeframe: Baseline, 4 WeeksPopulation: All randomized participants receiving at least 1 dose of the study drug and had evaluable data for serum potassium.
Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment\*visit and race.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo for blinding administered orally once daily for 4 weeks.
|
6 mg LY2623091
n=45 Participants
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
n=43 Participants
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
n=41 Participants
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
n=44 Participants
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
n=21 Participants
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
n=24 Participants
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline to 4 Weeks in Serum Potassium
|
-0.04 millimoles/L (mmol/L)
Standard Error 0.06
|
0.10 millimoles/L (mmol/L)
Standard Error 0.06
|
0.11 millimoles/L (mmol/L)
Standard Error 0.06
|
0.25 millimoles/L (mmol/L)
Standard Error 0.06
|
0.10 millimoles/L (mmol/L)
Standard Error 0.06
|
-0.06 millimoles/L (mmol/L)
Standard Error 0.08
|
0.30 millimoles/L (mmol/L)
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 2 hours post-dose at 4 WeeksPopulation: All participants who had evaluable PK data of LY2623091.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo for blinding administered orally once daily for 4 weeks.
|
6 mg LY2623091
n=40 Participants
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
n=36 Participants
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
n=39 Participants
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
|
122 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 32
|
228 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 37
|
379 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 51
|
206 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 53
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
6 mg LY2623091
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
13 mg LY2623091
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
24.5 mg LY2623091
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
13 mg LY2623091 + 20 mg Tadalafil
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
20 mg Tadalafil
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Spironolactone
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Placebo for blinding administered orally once daily for 4 weeks.
|
6 mg LY2623091
n=50 participants at risk
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
n=51 participants at risk
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
n=49 participants at risk
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
n=51 participants at risk
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
n=25 participants at risk
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
n=26 participants at risk
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Placebo for blinding administered orally once daily for 4 weeks.
|
6 mg LY2623091
n=50 participants at risk
6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091
n=51 participants at risk
13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
24.5 mg LY2623091
n=49 participants at risk
24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
|
13 mg LY2623091 + 20 mg Tadalafil
n=51 participants at risk
13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
20 mg Tadalafil
n=25 participants at risk
20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
|
Spironolactone
n=26 participants at risk
25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Investigations
Blood potassium increased
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Investigations
Blood pressure abnormal
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Investigations
Blood pressure increased
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.9%
2/51 • Number of events 3
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
2/50 • Number of events 3
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Investigations
Electrocardiogram t wave inversion
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Investigations
Heart rate increased
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Metabolism and nutrition disorders
Gout
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
5.9%
3/51 • Number of events 3
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
7.8%
4/51 • Number of events 4
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • Number of events 4
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
10.0%
5/50 • Number of events 5
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
19.6%
10/51 • Number of events 10
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
12.0%
3/25 • Number of events 3
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Nervous system disorders
Migraine
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
5.9%
3/51 • Number of events 3
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/35
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/33
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/27
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/29
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.3%
1/30 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/35
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/33
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/27
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/29
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/30
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
5.3%
1/19 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/35
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/33
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/27
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/29
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.3%
1/30 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/17
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/24
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/20
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/21
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/8
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/7
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
2/50 • Number of events 3
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Vascular disorders
Flushing
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Vascular disorders
Hot flush
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Vascular disorders
Hypertension
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
5.9%
3/51 • Number of events 3
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Eye disorders
Visual impairment
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
8.0%
2/25 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Faecal incontinence
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Faeces soft
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
5.9%
3/51 • Number of events 3
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
7.7%
2/26 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
5.9%
3/51 • Number of events 3
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
General disorders
Chest discomfort
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
General disorders
Fatigue
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
General disorders
Feeling abnormal
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
General disorders
Oedema peripheral
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
General disorders
Pain
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
General disorders
Peripheral swelling
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/35
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/33
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/27
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/29
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/30
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
5.9%
1/17 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/19
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
8.0%
4/50 • Number of events 4
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/49
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/50 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.9%
2/51 • Number of events 2
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
4.0%
1/25 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
3.8%
1/26 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/50
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/51
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
2.0%
1/51 • Number of events 1
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/25
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
0.00%
0/26
All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60