Trial Outcomes & Findings for A Study of LY2484595 in Patients With High LDL-C or Low HDL-C (NCT NCT01105975)
NCT ID: NCT01105975
Last Updated: 2018-03-22
Results Overview
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
398 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2018-03-22
Participant Flow
Participant milestones
| Measure |
30 mg LY2484595 Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 Monotherapy
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
Administered daily by mouth for 12 weeks
|
Placebo
Administered daily by mouth for 12 weeks
|
20 mg Atorvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
42
|
38
|
41
|
35
|
42
|
40
|
40
|
41
|
|
Overall Study
Took at Least One Dose of Study Drug
|
40
|
38
|
40
|
38
|
41
|
35
|
41
|
40
|
39
|
41
|
|
Overall Study
COMPLETED
|
35
|
34
|
32
|
36
|
35
|
30
|
34
|
33
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
10
|
2
|
6
|
5
|
8
|
7
|
6
|
9
|
Reasons for withdrawal
| Measure |
30 mg LY2484595 Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 Monotherapy
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
Administered daily by mouth for 12 weeks
|
Placebo
Administered daily by mouth for 12 weeks
|
20 mg Atorvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
5
|
1
|
0
|
1
|
2
|
4
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
0
|
4
|
1
|
2
|
1
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
2
|
0
|
1
|
1
|
1
|
1
|
2
|
2
|
|
Overall Study
Abnormal Lab/Electrocardiogram Result
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
1
|
2
|
0
|
Baseline Characteristics
A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
Baseline characteristics by cohort
| Measure |
30 mg LY2484595 Monotherapy
n=40 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 Monotherapy
n=38 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=40 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=38 Participants
Administered daily by mouth for 12 weeks
|
20 mg Atorvastatin Monotherapy
n=41 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=41 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=40 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=39 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=41 Participants
Administered daily by mouth for 12 weeks
|
Total
n=393 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
57.8 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
57.4 years
STANDARD_DEVIATION 11.8 • n=8 Participants
|
61.3 years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
58.4 years
STANDARD_DEVIATION 9.0 • n=24 Participants
|
57.4 years
STANDARD_DEVIATION 12.6 • n=42 Participants
|
59.7 years
STANDARD_DEVIATION 10.1 • n=42 Participants
|
58.3 years
STANDARD_DEVIATION 10.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
220 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
173 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
30 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
282 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
92 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
365 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
218 Participants
n=42 Participants
|
|
Region of Enrollment
Poland
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Region of Enrollment
Denmark
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
102 Participants
n=42 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Weight
|
84.6 kilogram
STANDARD_DEVIATION 23.2 • n=5 Participants
|
79.9 kilogram
STANDARD_DEVIATION 18.3 • n=7 Participants
|
82.6 kilogram
STANDARD_DEVIATION 20.6 • n=5 Participants
|
89.3 kilogram
STANDARD_DEVIATION 18.5 • n=4 Participants
|
81.4 kilogram
STANDARD_DEVIATION 16.4 • n=21 Participants
|
87.4 kilogram
STANDARD_DEVIATION 22.4 • n=8 Participants
|
79.6 kilogram
STANDARD_DEVIATION 15.4 • n=8 Participants
|
84.5 kilogram
STANDARD_DEVIATION 16.7 • n=24 Participants
|
85.7 kilogram
STANDARD_DEVIATION 19.4 • n=42 Participants
|
82.2 kilogram
STANDARD_DEVIATION 18.0 • n=42 Participants
|
83.6 kilogram
STANDARD_DEVIATION 19.0 • n=42 Participants
|
|
Body Mass Index (BMI)
|
29.8 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 7.8 • n=5 Participants
|
27.6 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 5.7 • n=7 Participants
|
29.0 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 5.6 • n=5 Participants
|
29.8 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 6.1 • n=4 Participants
|
28.8 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 5.1 • n=21 Participants
|
30.0 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 7.5 • n=8 Participants
|
28.3 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 5.0 • n=8 Participants
|
29.9 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 5.3 • n=24 Participants
|
28.3 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 4.2 • n=42 Participants
|
28.4 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 5.3 • n=42 Participants
|
29.0 kilogram/square meter (kg/m²)
STANDARD_DEVIATION 5.8 • n=42 Participants
|
|
High-Density Lipoprotein Cholesterol (HDL-C)
|
54.7 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 12.0 • n=5 Participants
|
57.0 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 14.1 • n=7 Participants
|
54.7 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 16.3 • n=5 Participants
|
53.0 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 11.8 • n=4 Participants
|
53.9 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 17.0 • n=21 Participants
|
55.7 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 18.2 • n=8 Participants
|
57.3 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 16.2 • n=8 Participants
|
53.7 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 13.6 • n=24 Participants
|
53.5 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 15.2 • n=42 Participants
|
57.8 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 18.1 • n=42 Participants
|
55.1 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 15.3 • n=42 Participants
|
|
Low-Density Lipoprotein Cholesterol (LDL-C)
|
143.5 mg/dL
STANDARD_DEVIATION 26.0 • n=5 Participants
|
148.0 mg/dL
STANDARD_DEVIATION 25.0 • n=7 Participants
|
135.7 mg/dL
STANDARD_DEVIATION 26.0 • n=5 Participants
|
147.3 mg/dL
STANDARD_DEVIATION 21.6 • n=4 Participants
|
139.0 mg/dL
STANDARD_DEVIATION 26.7 • n=21 Participants
|
143.6 mg/dL
STANDARD_DEVIATION 26.0 • n=8 Participants
|
154.8 mg/dL
STANDARD_DEVIATION 35.1 • n=8 Participants
|
143.7 mg/dL
STANDARD_DEVIATION 29.1 • n=24 Participants
|
141.6 mg/dL
STANDARD_DEVIATION 23.8 • n=42 Participants
|
145.7 mg/dL
STANDARD_DEVIATION 21.8 • n=42 Participants
|
144.3 mg/dL
STANDARD_DEVIATION 26.6 • n=42 Participants
|
|
Fasting Triglycerides
|
133.9 mg/dL
STANDARD_DEVIATION 56.6 • n=5 Participants
|
129.8 mg/dL
STANDARD_DEVIATION 51.7 • n=7 Participants
|
133.1 mg/dL
STANDARD_DEVIATION 69.8 • n=5 Participants
|
154.4 mg/dL
STANDARD_DEVIATION 93.0 • n=4 Participants
|
144.1 mg/dL
STANDARD_DEVIATION 83.4 • n=21 Participants
|
133.0 mg/dL
STANDARD_DEVIATION 67.8 • n=8 Participants
|
145.3 mg/dL
STANDARD_DEVIATION 84.6 • n=8 Participants
|
142.4 mg/dL
STANDARD_DEVIATION 62.4 • n=24 Participants
|
142.8 mg/dL
STANDARD_DEVIATION 65.6 • n=42 Participants
|
138.1 mg/dL
STANDARD_DEVIATION 69.0 • n=42 Participants
|
139.8 mg/dL
STANDARD_DEVIATION 71.1 • n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 HDL-C measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=34 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=31 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
Administered daily by mouth for 12 weeks
|
Placebo
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
|
1.4 percent change of mg/dL
Standard Error 5.7
|
79.9 percent change of mg/dL
Standard Error 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 LDL-C measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=31 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
Administered daily by mouth for 12 weeks
|
Placebo
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
|
-33.6 percent change of mg/dL
Standard Error 3.0
|
-47.6 percent change of mg/dL
Standard Error 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 HDL-C measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=33 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo
|
53.6 percent change of mg/dL
Standard Error 5.6
|
94.6 percent change of mg/dL
Standard Error 5.7
|
128.8 percent change of mg/dL
Standard Error 5.8
|
-3.0 percent change of mg/dL
Standard Error 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 LDL-C measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=33 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
|
-13.6 percent change of mg/dL
Standard Error 3.0
|
-22.3 percent change of mg/dL
Standard Error 3.0
|
-35.9 percent change of mg/dL
Standard Error 3.1
|
3.9 percent change of mg/dL
Standard Error 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 HDL-C measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=33 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
|
7.3 percent change of mg/dL
Standard Error 5.5
|
86.6 percent change of mg/dL
Standard Error 5.7
|
5.5 percent change of mg/dL
Standard Error 5.7
|
94.0 percent change of mg/dL
Standard Error 5.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 LDL-C measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=33 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
|
-34.9 percent change of mg/dL
Standard Error 3.0
|
-46.1 percent change of mg/dL
Standard Error 3.1
|
-38.8 percent change of mg/dL
Standard Error 3.0
|
-52.3 percent change of mg/dL
Standard Error 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 weeksPopulation: Participants who were administered LY2484595 and had pharmacokinetics (PK) samples.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=39 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=38 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=40 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=40 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=41 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State
|
2300 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.4
|
5900 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.4
|
19700 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.4
|
5500 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.4
|
5620 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.4
|
5960 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 CETP activity measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=31 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=34 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=30 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=33 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=32 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=34 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=30 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
|
-49.48 percent change of picomoles/mL/minute
Standard Error 3.75
|
-70.80 percent change of picomoles/mL/minute
Standard Error 3.89
|
-89.10 percent change of picomoles/mL/minute
Standard Error 4.00
|
12.12 percent change of picomoles/mL/minute
Standard Error 3.75
|
-0.01 percent change of picomoles/mL/minute
Standard Error 3.81
|
-72.00 percent change of picomoles/mL/minute
Standard Error 4.01
|
-2.23 percent change of picomoles/mL/minute
Standard Error 3.80
|
-64.64 percent change of picomoles/mL/minute
Standard Error 3.86
|
-7.19 percent change of picomoles/mL/minute
Standard Error 3.80
|
-73.24 percent change of picomoles/mL/minute
Standard Error 3.96
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 CETP mass measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=32 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=31 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=34 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=30 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass
|
63.94 percent change of micrograms/mL (mcg/mL)
Standard Error 5.54
|
92.27 percent change of micrograms/mL (mcg/mL)
Standard Error 5.59
|
136.66 percent change of micrograms/mL (mcg/mL)
Standard Error 5.83
|
0.58 percent change of micrograms/mL (mcg/mL)
Standard Error 5.51
|
-11.8 percent change of micrograms/mL (mcg/mL)
Standard Error 5.48
|
62.98 percent change of micrograms/mL (mcg/mL)
Standard Error 5.87
|
-11.14 percent change of micrograms/mL (mcg/mL)
Standard Error 5.50
|
65.92 percent change of micrograms/mL (mcg/mL)
Standard Error 5.63
|
-16.58 percent change of micrograms/mL (mcg/mL)
Standard Error 5.62
|
64.08 percent change of micrograms/mL (mcg/mL)
Standard Error 5.81
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: Participants who took study drug.
All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=40 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=38 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=40 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=38 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=41 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=41 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=40 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=39 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=41 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
High Risk (HR)- Angioedema
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
1 events
|
0 events
|
0 events
|
0 events
|
|
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
HR - Insufficient Documentation for Determination
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
1 events
|
|
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
Low Risk
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
1 events
|
0 events
|
2 events
|
|
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
Not a Relevant Dermatoses
|
4 events
|
5 events
|
3 events
|
0 events
|
1 events
|
2 events
|
6 events
|
4 events
|
0 events
|
1 events
|
|
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
Insufficient Documentation for Determination
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 BP measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=33 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=30 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)
Diastolic BP
|
1.1 millimeters of mercury (mmHg)
Standard Error 1.1
|
0.8 millimeters of mercury (mmHg)
Standard Error 1.1
|
1.2 millimeters of mercury (mmHg)
Standard Error 1.2
|
1.6 millimeters of mercury (mmHg)
Standard Error 1.1
|
0.2 millimeters of mercury (mmHg)
Standard Error 1.1
|
1.2 millimeters of mercury (mmHg)
Standard Error 1.2
|
-1.5 millimeters of mercury (mmHg)
Standard Error 1.1
|
2.3 millimeters of mercury (mmHg)
Standard Error 1.2
|
2.2 millimeters of mercury (mmHg)
Standard Error 1.1
|
-0.1 millimeters of mercury (mmHg)
Standard Error 1.1
|
|
Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)
Systolic BP
|
4.4 millimeters of mercury (mmHg)
Standard Error 1.8
|
4.3 millimeters of mercury (mmHg)
Standard Error 1.8
|
1.4 millimeters of mercury (mmHg)
Standard Error 1.8
|
2.8 millimeters of mercury (mmHg)
Standard Error 1.7
|
0.2 millimeters of mercury (mmHg)
Standard Error 1.7
|
2.1 millimeters of mercury (mmHg)
Standard Error 1.9
|
0.0 millimeters of mercury (mmHg)
Standard Error 1.7
|
2.3 millimeters of mercury (mmHg)
Standard Error 1.8
|
0.0 millimeters of mercury (mmHg)
Standard Error 1.8
|
3.8 millimeters of mercury (mmHg)
Standard Error 1.8
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 aldosterone measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=34 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=33 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=31 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=34 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=32 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone
|
-0.5 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
1.0 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
-0.3 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
-1.0 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
-1.0 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
0.4 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
0.0 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
-1.7 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
-2.5 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
0.0 nanogram/deciliter (ng/dL)
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 renin activity measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=33 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=32 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=34 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=28 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=33 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=32 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=29 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity
|
-0.06 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.34
|
-0.11 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.34
|
-0.58 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.35
|
-0.30 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.34
|
-0.58 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.34
|
-0.26 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.37
|
-0.16 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.34
|
0.00 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.34
|
-0.86 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.33
|
-0.29 nanograms/milliliter/hour (ng/mL/h)
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 potassium measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=33 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=31 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks Endpoint in Serum Potassium
|
-0.04 milliequivalents/Liter
Standard Error 0.05
|
0.01 milliequivalents/Liter
Standard Error 0.05
|
-0.02 milliequivalents/Liter
Standard Error 0.05
|
-0.08 milliequivalents/Liter
Standard Error 0.05
|
0.09 milliequivalents/Liter
Standard Error 0.05
|
0.08 milliequivalents/Liter
Standard Error 0.05
|
0.03 milliequivalents/Liter
Standard Error 0.05
|
0.02 milliequivalents/Liter
Standard Error 0.05
|
-0.07 milliequivalents/Liter
Standard Error 0.05
|
-0.05 milliequivalents/Liter
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 sodium measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=33 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=31 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks Endpoint in Serum Sodium
|
0.3 milliequivalents/Liter
Standard Error 0.4
|
0.3 milliequivalents/Liter
Standard Error 0.4
|
0.5 milliequivalents/Liter
Standard Error 0.4
|
0.1 milliequivalents/Liter
Standard Error 0.4
|
1.3 milliequivalents/Liter
Standard Error 0.4
|
0.6 milliequivalents/Liter
Standard Error 0.4
|
0.8 milliequivalents/Liter
Standard Error 0.4
|
0.9 milliequivalents/Liter
Standard Error 0.4
|
0.5 milliequivalents/Liter
Standard Error 0.4
|
0.3 milliequivalents/Liter
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants who had both baseline and Week 12 bicarbonate measurements.
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=34 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=32 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=34 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=31 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=35 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=33 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate
|
0.40 milliequivalents/Liter
Standard Error 0.36
|
0.60 milliequivalents/Liter
Standard Error 0.36
|
0.51 milliequivalents/Liter
Standard Error 0.37
|
0.27 milliequivalents/Liter
Standard Error 0.36
|
0.10 milliequivalents/Liter
Standard Error 0.36
|
0.58 milliequivalents/Liter
Standard Error 0.38
|
1.04 milliequivalents/Liter
Standard Error 0.35
|
0.58 milliequivalents/Liter
Standard Error 0.37
|
0.78 milliequivalents/Liter
Standard Error 0.36
|
1.25 milliequivalents/Liter
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline up to Week 18Population: Participants who had both baseline and at least one post-baseline EQ-5D measurements, last observation carried forward (LOCF).
EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Outcome measures
| Measure |
20 mg Atorvastatin Monotherapy
n=37 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=36 Participants
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=39 Participants
Administered daily by mouth for 12 weeks
|
Placebo
n=36 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=39 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=35 Participants
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=39 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=40 Participants
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=39 Participants
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=41 Participants
Administered daily by mouth for 12 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score
|
0.008 units on a scale
Standard Error 0.014
|
0.002 units on a scale
Standard Error 0.014
|
0.012 units on a scale
Standard Error 0.014
|
-0.001 units on a scale
Standard Error 0.014
|
-0.002 units on a scale
Standard Error 0.014
|
-0.006 units on a scale
Standard Error 0.014
|
-0.001 units on a scale
Standard Error 0.014
|
-0.001 units on a scale
Standard Error 0.013
|
0.014 units on a scale
Standard Error 0.014
|
-0.047 units on a scale
Standard Error 0.013
|
Adverse Events
30 mg LY2484595 Monotherapy
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
100 mg LY2484595 Monotherapy
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
500 mg LY2484595 Monotherapy
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
20 mg Atorvastatin Monotherapy
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
100 mg LY2484595 + 20 mg Atorvastatin
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
40 mg Simvastatin Monotherapy
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
100 mg LY2484595 + 40 mg Simvastatin
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
10 mg Rosuvastatin Monotherapy
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
100 mg LY2484595 + 10 mg Rosuvastatin
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
30 mg LY2484595 Monotherapy Follow-Up
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
100 mg LY2484595 Monotherapy Follow-Up
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
500 mg LY2484595 Monotherapy Follow-Up
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Follow-Up
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
20 mg Atorvastatin Monotherapy Follow-Up
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
100 mg LY2484595 + 20 mg Atorvastatin Follow-Up
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
40 mg Simvastatin Monotherapy Follow-Up
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
100 mg LY2484595 + 40 mg Simvastatin Follow-Up
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
10 mg Rosuvastatin Monotherapy Follow-Up
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
30 mg LY2484595 Monotherapy
n=40 participants at risk
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 Monotherapy
n=38 participants at risk
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=40 participants at risk
Administered daily by mouth for 12 weeks
|
Placebo
n=38 participants at risk
Administered daily by mouth for 12 weeks
|
20 mg Atorvastatin Monotherapy
n=41 participants at risk
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 participants at risk
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=41 participants at risk
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=40 participants at risk
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=39 participants at risk
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=41 participants at risk
Administered daily by mouth for 12 weeks
|
30 mg LY2484595 Monotherapy Follow-Up
n=40 participants at risk
30 day follow-up period after last dose of study drug
|
100 mg LY2484595 Monotherapy Follow-Up
n=38 participants at risk
30 day follow-up period after last dose of study drug
|
500 mg LY2484595 Monotherapy Follow-Up
n=40 participants at risk
30 day follow-up period after last dose of study drug
|
Placebo Follow-Up
n=38 participants at risk
30 day follow-up period after last dose of study drug
|
20 mg Atorvastatin Monotherapy Follow-Up
n=41 participants at risk
30 day follow-up period after last dose of study drug
|
100 mg LY2484595 + 20 mg Atorvastatin Follow-Up
n=35 participants at risk
30 day follow-up period after last dose of study drug
|
40 mg Simvastatin Monotherapy Follow-Up
n=41 participants at risk
30 day follow-up period after last dose of study drug
|
100 mg LY2484595 + 40 mg Simvastatin Follow-Up
n=40 participants at risk
30 day follow-up period after last dose of study drug
|
10 mg Rosuvastatin Monotherapy Follow-Up
n=39 participants at risk
30 day follow-up period after last dose of study drug
|
100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up
n=41 participants at risk
30 day follow-up period after last dose of study drug
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Influenza
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
Other adverse events
| Measure |
30 mg LY2484595 Monotherapy
n=40 participants at risk
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 Monotherapy
n=38 participants at risk
Administered daily by mouth for 12 weeks
|
500 mg LY2484595 Monotherapy
n=40 participants at risk
Administered daily by mouth for 12 weeks
|
Placebo
n=38 participants at risk
Administered daily by mouth for 12 weeks
|
20 mg Atorvastatin Monotherapy
n=41 participants at risk
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 20 mg Atorvastatin
n=35 participants at risk
Administered daily by mouth for 12 weeks
|
40 mg Simvastatin Monotherapy
n=41 participants at risk
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 40 mg Simvastatin
n=40 participants at risk
Administered daily by mouth for 12 weeks
|
10 mg Rosuvastatin Monotherapy
n=39 participants at risk
Administered daily by mouth for 12 weeks
|
100 mg LY2484595 + 10 mg Rosuvastatin
n=41 participants at risk
Administered daily by mouth for 12 weeks
|
30 mg LY2484595 Monotherapy Follow-Up
n=40 participants at risk
30 day follow-up period after last dose of study drug
|
100 mg LY2484595 Monotherapy Follow-Up
n=38 participants at risk
30 day follow-up period after last dose of study drug
|
500 mg LY2484595 Monotherapy Follow-Up
n=40 participants at risk
30 day follow-up period after last dose of study drug
|
Placebo Follow-Up
n=38 participants at risk
30 day follow-up period after last dose of study drug
|
20 mg Atorvastatin Monotherapy Follow-Up
n=41 participants at risk
30 day follow-up period after last dose of study drug
|
100 mg LY2484595 + 20 mg Atorvastatin Follow-Up
n=35 participants at risk
30 day follow-up period after last dose of study drug
|
40 mg Simvastatin Monotherapy Follow-Up
n=41 participants at risk
30 day follow-up period after last dose of study drug
|
100 mg LY2484595 + 40 mg Simvastatin Follow-Up
n=40 participants at risk
30 day follow-up period after last dose of study drug
|
10 mg Rosuvastatin Monotherapy Follow-Up
n=39 participants at risk
30 day follow-up period after last dose of study drug
|
100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up
n=41 participants at risk
30 day follow-up period after last dose of study drug
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Herpes simplex
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Laryngitis
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Renal and urinary disorders
Pollakiuria
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Influenza
|
0.00%
0/40
|
5.3%
2/38 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 2
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Cardiac disorders
Palpitations
|
0.00%
0/40
|
5.3%
2/38 • Number of events 2
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Ear and labyrinth disorders
Tinnitus
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 2
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Eye disorders
Borderline glaucoma
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Eye disorders
Photopsia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
2.6%
1/38 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
4.9%
2/41 • Number of events 2
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40
|
5.3%
2/38 • Number of events 2
|
7.5%
3/40 • Number of events 3
|
2.6%
1/38 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
5.7%
2/35 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
5.1%
2/39 • Number of events 2
|
4.9%
2/41 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40 • Number of events 2
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
5.3%
2/38 • Number of events 2
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
7.3%
3/41 • Number of events 3
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40
|
0.00%
0/38
|
7.5%
3/40 • Number of events 3
|
2.6%
1/38 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
8.6%
3/35 • Number of events 3
|
2.4%
1/41 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
2.6%
1/39 • Number of events 1
|
9.8%
4/41 • Number of events 5
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
General disorders
Asthenia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
General disorders
Fatigue
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
5.1%
2/39 • Number of events 2
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
General disorders
Feeling hot
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
General disorders
Influenza like illness
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Localised oedema
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
General disorders
Malaise
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
General disorders
Oedema
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
General disorders
Oedema peripheral
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
General disorders
Pyrexia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
General disorders
Thirst
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Immune system disorders
Seasonal allergy
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Bronchitis
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Infections and infestations
Cellulitis
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Cystitis
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Ear infection
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
5.7%
2/35 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Localised infection
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40 • Number of events 2
|
7.9%
3/38 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
15.8%
6/38 • Number of events 6
|
9.8%
4/41 • Number of events 4
|
17.1%
6/35 • Number of events 6
|
9.8%
4/41 • Number of events 4
|
10.0%
4/40 • Number of events 4
|
23.1%
9/39 • Number of events 9
|
7.3%
3/41 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Otitis media
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Paronychia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Rhinitis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
4.9%
2/41 • Number of events 2
|
0.00%
0/35
|
4.9%
2/41 • Number of events 3
|
0.00%
0/40
|
0.00%
0/39
|
4.9%
2/41 • Number of events 2
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Tooth infection
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Tracheitis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Infections and infestations
Viral infection
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Blood aldosterone decreased
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Blood bilirubin abnormal
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Blood glucose increased
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Blood potassium decreased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Blood pressure increased
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
4.9%
2/41 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
7.3%
3/41 • Number of events 3
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Blood uric acid abnormal
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Heart rate irregular
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Liver function test abnormal
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Renin increased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Investigations
Weight increased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
0.00%
0/38
|
7.3%
3/41 • Number of events 4
|
5.7%
2/35 • Number of events 2
|
0.00%
0/41
|
7.5%
3/40 • Number of events 3
|
2.6%
1/39 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 2
|
2.6%
1/38 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
5.7%
2/35 • Number of events 2
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Amnesia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 2
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40
|
5.3%
2/38 • Number of events 3
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
0.00%
0/39
|
7.3%
3/41 • Number of events 3
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Number of events 2
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 2
|
9.8%
4/41 • Number of events 4
|
0.00%
0/35
|
0.00%
0/41
|
5.0%
2/40 • Number of events 2
|
5.1%
2/39 • Number of events 2
|
7.3%
3/41 • Number of events 3
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Hemicephalalgia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Lethargy
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Migraine
|
0.00%
0/40
|
5.3%
2/38 • Number of events 2
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Sciatica
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 2
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Psychiatric disorders
Affective disorder
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Psychiatric disorders
Agitation
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Psychiatric disorders
Insomnia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
5.0%
2/40 • Number of events 2
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Psychiatric disorders
Mood swings
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Reproductive system and breast disorders
Ovarian enlargement
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
5.3%
2/38 • Number of events 3
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 2
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
4.9%
2/41 • Number of events 2
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
2.9%
1/35 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 2
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
1/40 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
4.9%
2/41 • Number of events 2
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/40
|
0.00%
0/38
|
2.5%
1/40 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • Number of events 1
|
5.3%
2/38 • Number of events 4
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
4.9%
2/41 • Number of events 4
|
7.5%
3/40 • Number of events 3
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
2.4%
1/41 • Number of events 1
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
2.6%
1/39 • Number of events 1
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Vascular disorders
Hot flush
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1
|
0.00%
0/38
|
0.00%
0/40
|
2.6%
1/38 • Number of events 1
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
|
Vascular disorders
Hypotension
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
0.00%
0/39
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/40
|
0.00%
0/38
|
0.00%
0/41
|
0.00%
0/35
|
0.00%
0/41
|
0.00%
0/40
|
0.00%
0/39
|
0.00%
0/41
|
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