Trial Outcomes & Findings for LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 (NCT NCT01763866)
NCT ID: NCT01763866
Last Updated: 2022-11-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2067 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2022-11-08
Participant Flow
Adults aged 18 to 80 years with screening low-density lipoprotein cholesterol (LDL-C) ≥ 150 mg/dL (no statin at screening), ≥ 100 mg/dL (non-intensive statin at screening), or ≥ 80 mg/dL (intensive statin at screening) and fasting triglycerides ≤ 400 mg/dL. First patient enrolled on 15 January 2013; Last patient enrolled on 10 July 2013.
2067 patients were first randomized to 1 of the 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg); 1899 were then randomized to blinded investigational product. Randomization into the statin dose cohorts was stratified by entry statin therapy and by use of certain concomitant medications.
Participant milestones
| Measure |
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
55
|
56
|
55
|
110
|
110
|
55
|
55
|
56
|
54
|
110
|
110
|
58
|
57
|
114
|
115
|
56
|
56
|
111
|
112
|
56
|
55
|
112
|
115
|
|
Overall Study
Received Treatment
|
56
|
55
|
56
|
55
|
110
|
110
|
55
|
55
|
56
|
54
|
109
|
110
|
58
|
57
|
113
|
115
|
56
|
55
|
111
|
112
|
56
|
55
|
112
|
115
|
|
Overall Study
COMPLETED
|
54
|
54
|
51
|
55
|
108
|
107
|
48
|
55
|
53
|
53
|
102
|
108
|
54
|
57
|
102
|
112
|
55
|
55
|
105
|
110
|
52
|
54
|
109
|
113
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
5
|
0
|
2
|
3
|
7
|
0
|
3
|
1
|
8
|
2
|
4
|
0
|
12
|
3
|
1
|
1
|
6
|
2
|
4
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
4
|
0
|
0
|
3
|
4
|
0
|
1
|
1
|
2
|
2
|
2
|
0
|
6
|
3
|
0
|
1
|
1
|
1
|
2
|
1
|
2
|
1
|
|
Overall Study
Decision by sponsor
|
0
|
0
|
1
|
0
|
2
|
0
|
2
|
0
|
2
|
0
|
6
|
0
|
1
|
0
|
5
|
0
|
0
|
0
|
4
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
Baseline characteristics by cohort
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=114 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
Total
n=1899 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
58.3 years
STANDARD_DEVIATION 8.4 • n=21 Participants
|
59.6 years
STANDARD_DEVIATION 11.1 • n=10 Participants
|
57.1 years
STANDARD_DEVIATION 9.9 • n=115 Participants
|
58.8 years
STANDARD_DEVIATION 11.5 • n=6 Participants
|
60.5 years
STANDARD_DEVIATION 10.2 • n=6 Participants
|
61.1 years
STANDARD_DEVIATION 8.9 • n=64 Participants
|
59.7 years
STANDARD_DEVIATION 10.2 • n=17 Participants
|
60.1 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
61.2 years
STANDARD_DEVIATION 9.1 • n=22 Participants
|
59.6 years
STANDARD_DEVIATION 9.2 • n=8 Participants
|
58.9 years
STANDARD_DEVIATION 11.2 • n=16 Participants
|
59.3 years
STANDARD_DEVIATION 10.5 • n=135 Participants
|
60.2 years
STANDARD_DEVIATION 8.7 • n=136 Participants
|
58.3 years
STANDARD_DEVIATION 11.3 • n=44 Participants
|
59.5 years
STANDARD_DEVIATION 9.2 • n=667 Participants
|
59.6 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 9.7 • n=6 Participants
|
61.5 years
STANDARD_DEVIATION 10.3 • n=10 Participants
|
59.7 years
STANDARD_DEVIATION 9.2 • n=14 Participants
|
61.5 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
24 Participants
n=6 Participants
|
28 Participants
n=64 Participants
|
44 Participants
n=17 Participants
|
48 Participants
n=21 Participants
|
35 Participants
n=22 Participants
|
27 Participants
n=8 Participants
|
52 Participants
n=16 Participants
|
51 Participants
n=135 Participants
|
21 Participants
n=136 Participants
|
27 Participants
n=44 Participants
|
43 Participants
n=667 Participants
|
52 Participants
n=7 Participants
|
32 Participants
n=6 Participants
|
28 Participants
n=10 Participants
|
45 Participants
n=14 Participants
|
59 Participants
n=4 Participants
|
871 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
66 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
31 Participants
n=6 Participants
|
32 Participants
n=6 Participants
|
26 Participants
n=64 Participants
|
66 Participants
n=17 Participants
|
62 Participants
n=21 Participants
|
23 Participants
n=22 Participants
|
30 Participants
n=8 Participants
|
62 Participants
n=16 Participants
|
64 Participants
n=135 Participants
|
35 Participants
n=136 Participants
|
29 Participants
n=44 Participants
|
68 Participants
n=667 Participants
|
60 Participants
n=7 Participants
|
24 Participants
n=6 Participants
|
27 Participants
n=10 Participants
|
67 Participants
n=14 Participants
|
56 Participants
n=4 Participants
|
1028 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
2 participants
n=10 Participants
|
5 participants
n=115 Participants
|
5 participants
n=6 Participants
|
4 participants
n=6 Participants
|
4 participants
n=64 Participants
|
5 participants
n=17 Participants
|
7 participants
n=21 Participants
|
2 participants
n=22 Participants
|
4 participants
n=8 Participants
|
6 participants
n=16 Participants
|
3 participants
n=135 Participants
|
2 participants
n=136 Participants
|
3 participants
n=44 Participants
|
6 participants
n=667 Participants
|
5 participants
n=7 Participants
|
1 participants
n=6 Participants
|
2 participants
n=10 Participants
|
3 participants
n=14 Participants
|
5 participants
n=4 Participants
|
87 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
53 participants
n=5 Participants
|
53 participants
n=7 Participants
|
54 participants
n=5 Participants
|
54 participants
n=4 Participants
|
105 participants
n=21 Participants
|
108 participants
n=10 Participants
|
50 participants
n=115 Participants
|
50 participants
n=6 Participants
|
52 participants
n=6 Participants
|
50 participants
n=64 Participants
|
105 participants
n=17 Participants
|
103 participants
n=21 Participants
|
56 participants
n=22 Participants
|
53 participants
n=8 Participants
|
108 participants
n=16 Participants
|
112 participants
n=135 Participants
|
54 participants
n=136 Participants
|
53 participants
n=44 Participants
|
105 participants
n=667 Participants
|
107 participants
n=7 Participants
|
55 participants
n=6 Participants
|
53 participants
n=10 Participants
|
109 participants
n=14 Participants
|
110 participants
n=4 Participants
|
1812 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
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=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
0 participants
n=16 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
0 participants
n=7 Participants
|
0 participants
n=6 Participants
|
0 participants
n=10 Participants
|
1 participants
n=14 Participants
|
0 participants
n=4 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
4 participants
n=10 Participants
|
1 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
3 participants
n=64 Participants
|
1 participants
n=17 Participants
|
1 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
2 participants
n=16 Participants
|
1 participants
n=135 Participants
|
1 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
0 participants
n=7 Participants
|
3 participants
n=6 Participants
|
0 participants
n=10 Participants
|
1 participants
n=14 Participants
|
0 participants
n=4 Participants
|
25 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
9 participants
n=21 Participants
|
4 participants
n=10 Participants
|
1 participants
n=115 Participants
|
2 participants
n=6 Participants
|
3 participants
n=6 Participants
|
4 participants
n=64 Participants
|
3 participants
n=17 Participants
|
4 participants
n=21 Participants
|
2 participants
n=22 Participants
|
1 participants
n=8 Participants
|
7 participants
n=16 Participants
|
5 participants
n=135 Participants
|
0 participants
n=136 Participants
|
3 participants
n=44 Participants
|
5 participants
n=667 Participants
|
3 participants
n=7 Participants
|
3 participants
n=6 Participants
|
1 participants
n=10 Participants
|
4 participants
n=14 Participants
|
5 participants
n=4 Participants
|
75 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
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=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=6 Participants
|
0 participants
n=6 Participants
|
1 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
0 participants
n=16 Participants
|
1 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
0 participants
n=7 Participants
|
1 participants
n=6 Participants
|
0 participants
n=10 Participants
|
0 participants
n=14 Participants
|
0 participants
n=4 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
52 participants
n=5 Participants
|
55 participants
n=7 Participants
|
53 participants
n=5 Participants
|
52 participants
n=4 Participants
|
97 participants
n=21 Participants
|
101 participants
n=10 Participants
|
51 participants
n=115 Participants
|
52 participants
n=6 Participants
|
53 participants
n=6 Participants
|
46 participants
n=64 Participants
|
105 participants
n=17 Participants
|
105 participants
n=21 Participants
|
56 participants
n=22 Participants
|
56 participants
n=8 Participants
|
104 participants
n=16 Participants
|
107 participants
n=135 Participants
|
55 participants
n=136 Participants
|
52 participants
n=44 Participants
|
105 participants
n=667 Participants
|
109 participants
n=7 Participants
|
49 participants
n=6 Participants
|
54 participants
n=10 Participants
|
106 participants
n=14 Participants
|
110 participants
n=4 Participants
|
1785 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=64 Participants
|
1 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
1 participants
n=16 Participants
|
1 participants
n=135 Participants
|
0 participants
n=136 Participants
|
1 participants
n=44 Participants
|
0 participants
n=667 Participants
|
0 participants
n=7 Participants
|
0 participants
n=6 Participants
|
0 participants
n=10 Participants
|
0 participants
n=14 Participants
|
0 participants
n=4 Participants
|
7 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
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
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
0 participants
n=16 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
1 participants
n=667 Participants
|
0 participants
n=7 Participants
|
0 participants
n=6 Participants
|
0 participants
n=10 Participants
|
0 participants
n=14 Participants
|
0 participants
n=4 Participants
|
2 participants
n=4 Participants
|
|
Stratification Factor: Entry Statin Therapy
Intensive statin use
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
10 participants
n=5 Participants
|
14 participants
n=4 Participants
|
28 participants
n=21 Participants
|
35 participants
n=10 Participants
|
15 participants
n=115 Participants
|
12 participants
n=6 Participants
|
21 participants
n=6 Participants
|
11 participants
n=64 Participants
|
34 participants
n=17 Participants
|
35 participants
n=21 Participants
|
13 participants
n=22 Participants
|
13 participants
n=8 Participants
|
33 participants
n=16 Participants
|
38 participants
n=135 Participants
|
13 participants
n=136 Participants
|
13 participants
n=44 Participants
|
33 participants
n=667 Participants
|
37 participants
n=7 Participants
|
19 participants
n=6 Participants
|
13 participants
n=10 Participants
|
31 participants
n=14 Participants
|
34 participants
n=4 Participants
|
542 participants
n=4 Participants
|
|
Stratification Factor: Entry Statin Therapy
Non-intensive statin use
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
30 participants
n=5 Participants
|
21 participants
n=4 Participants
|
52 participants
n=21 Participants
|
40 participants
n=10 Participants
|
22 participants
n=115 Participants
|
27 participants
n=6 Participants
|
22 participants
n=6 Participants
|
21 participants
n=64 Participants
|
47 participants
n=17 Participants
|
46 participants
n=21 Participants
|
25 participants
n=22 Participants
|
28 participants
n=8 Participants
|
49 participants
n=16 Participants
|
42 participants
n=135 Participants
|
23 participants
n=136 Participants
|
22 participants
n=44 Participants
|
50 participants
n=667 Participants
|
44 participants
n=7 Participants
|
21 participants
n=6 Participants
|
26 participants
n=10 Participants
|
45 participants
n=14 Participants
|
48 participants
n=4 Participants
|
796 participants
n=4 Participants
|
|
Stratification Factor: Entry Statin Therapy
No statin use
|
18 participants
n=5 Participants
|
11 participants
n=7 Participants
|
16 participants
n=5 Participants
|
20 participants
n=4 Participants
|
30 participants
n=21 Participants
|
35 participants
n=10 Participants
|
18 participants
n=115 Participants
|
16 participants
n=6 Participants
|
13 participants
n=6 Participants
|
22 participants
n=64 Participants
|
29 participants
n=17 Participants
|
29 participants
n=21 Participants
|
20 participants
n=22 Participants
|
16 participants
n=8 Participants
|
32 participants
n=16 Participants
|
35 participants
n=135 Participants
|
20 participants
n=136 Participants
|
21 participants
n=44 Participants
|
28 participants
n=667 Participants
|
31 participants
n=7 Participants
|
16 participants
n=6 Participants
|
16 participants
n=10 Participants
|
36 participants
n=14 Participants
|
33 participants
n=4 Participants
|
561 participants
n=4 Participants
|
|
Low-Density Lipoprotein Cholesterol (LDL-C) Concentration
|
123.0 mg/dL
STANDARD_DEVIATION 46.6 • n=5 Participants
|
123.7 mg/dL
STANDARD_DEVIATION 47.9 • n=7 Participants
|
126.8 mg/dL
STANDARD_DEVIATION 49.6 • n=5 Participants
|
119.3 mg/dL
STANDARD_DEVIATION 28.1 • n=4 Participants
|
124.2 mg/dL
STANDARD_DEVIATION 43.4 • n=21 Participants
|
126.1 mg/dL
STANDARD_DEVIATION 50.4 • n=10 Participants
|
100.3 mg/dL
STANDARD_DEVIATION 36.2 • n=115 Participants
|
94.7 mg/dL
STANDARD_DEVIATION 31.9 • n=6 Participants
|
98.7 mg/dL
STANDARD_DEVIATION 34.0 • n=6 Participants
|
92.3 mg/dL
STANDARD_DEVIATION 19.3 • n=64 Participants
|
94.2 mg/dL
STANDARD_DEVIATION 34.8 • n=17 Participants
|
93.8 mg/dL
STANDARD_DEVIATION 32.3 • n=21 Participants
|
115.6 mg/dL
STANDARD_DEVIATION 39.8 • n=22 Participants
|
119.9 mg/dL
STANDARD_DEVIATION 39.1 • n=8 Participants
|
118.7 mg/dL
STANDARD_DEVIATION 40.9 • n=16 Participants
|
122.9 mg/dL
STANDARD_DEVIATION 42.0 • n=135 Participants
|
77.4 mg/dL
STANDARD_DEVIATION 20.9 • n=136 Participants
|
102.9 mg/dL
STANDARD_DEVIATION 49.3 • n=44 Participants
|
88.5 mg/dL
STANDARD_DEVIATION 31.5 • n=667 Participants
|
88.5 mg/dL
STANDARD_DEVIATION 31.3 • n=7 Participants
|
110.3 mg/dL
STANDARD_DEVIATION 28.0 • n=6 Participants
|
108.6 mg/dL
STANDARD_DEVIATION 30.9 • n=10 Participants
|
114.9 mg/dL
STANDARD_DEVIATION 34.5 • n=14 Participants
|
123.7 mg/dL
STANDARD_DEVIATION 48.5 • n=4 Participants
|
109.1 mg/dL
STANDARD_DEVIATION 41.1 • n=4 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
|
149.1 mg/dL
STANDARD_DEVIATION 46.9 • n=5 Participants
|
147.7 mg/dL
STANDARD_DEVIATION 51.4 • n=7 Participants
|
153.8 mg/dL
STANDARD_DEVIATION 53.2 • n=5 Participants
|
148.3 mg/dL
STANDARD_DEVIATION 36.8 • n=4 Participants
|
152.3 mg/dL
STANDARD_DEVIATION 45.6 • n=21 Participants
|
154.3 mg/dL
STANDARD_DEVIATION 53.1 • n=10 Participants
|
124.2 mg/dL
STANDARD_DEVIATION 39.3 • n=115 Participants
|
116.5 mg/dL
STANDARD_DEVIATION 35.7 • n=6 Participants
|
124.8 mg/dL
STANDARD_DEVIATION 35.4 • n=6 Participants
|
118.4 mg/dL
STANDARD_DEVIATION 25.5 • n=64 Participants
|
120.2 mg/dL
STANDARD_DEVIATION 42.3 • n=17 Participants
|
117.2 mg/dL
STANDARD_DEVIATION 36.3 • n=21 Participants
|
141.1 mg/dL
STANDARD_DEVIATION 41.6 • n=22 Participants
|
148.3 mg/dL
STANDARD_DEVIATION 43.3 • n=8 Participants
|
146.6 mg/dL
STANDARD_DEVIATION 43.2 • n=16 Participants
|
152.0 mg/dL
STANDARD_DEVIATION 46.4 • n=135 Participants
|
103.9 mg/dL
STANDARD_DEVIATION 25.7 • n=136 Participants
|
128.7 mg/dL
STANDARD_DEVIATION 53.4 • n=44 Participants
|
113.5 mg/dL
STANDARD_DEVIATION 36.0 • n=667 Participants
|
114.3 mg/dL
STANDARD_DEVIATION 34.7 • n=7 Participants
|
138.4 mg/dL
STANDARD_DEVIATION 29.3 • n=6 Participants
|
135.7 mg/dL
STANDARD_DEVIATION 38.4 • n=10 Participants
|
146.8 mg/dL
STANDARD_DEVIATION 41.8 • n=14 Participants
|
151.2 mg/dL
STANDARD_DEVIATION 51.5 • n=4 Participants
|
150.3 mg/dL
STANDARD_DEVIATION 27.6 • n=4 Participants
|
|
Apolipoprotein B Concentration
|
95.3 mg/dL
STANDARD_DEVIATION 26.0 • n=5 Participants
|
95.3 mg/dL
STANDARD_DEVIATION 29.6 • n=7 Participants
|
101.3 mg/dL
STANDARD_DEVIATION 31.2 • n=5 Participants
|
94.6 mg/dL
STANDARD_DEVIATION 20.4 • n=4 Participants
|
99.7 mg/dL
STANDARD_DEVIATION 26.4 • n=21 Participants
|
97.3 mg/dL
STANDARD_DEVIATION 28.9 • n=10 Participants
|
81.1 mg/dL
STANDARD_DEVIATION 22.1 • n=115 Participants
|
80.1 mg/dL
STANDARD_DEVIATION 21.4 • n=6 Participants
|
85.3 mg/dL
STANDARD_DEVIATION 23.1 • n=6 Participants
|
78.7 mg/dL
STANDARD_DEVIATION 16.9 • n=64 Participants
|
79.9 mg/dL
STANDARD_DEVIATION 25.1 • n=17 Participants
|
77.9 mg/dL
STANDARD_DEVIATION 21.5 • n=21 Participants
|
93.1 mg/dL
STANDARD_DEVIATION 27.3 • n=22 Participants
|
95.9 mg/dL
STANDARD_DEVIATION 25.2 • n=8 Participants
|
95.4 mg/dL
STANDARD_DEVIATION 27.0 • n=16 Participants
|
97.2 mg/dL
STANDARD_DEVIATION 26.9 • n=135 Participants
|
71.0 mg/dL
STANDARD_DEVIATION 16.6 • n=136 Participants
|
84.8 mg/dL
STANDARD_DEVIATION 29.7 • n=44 Participants
|
77.4 mg/dL
STANDARD_DEVIATION 22.3 • n=667 Participants
|
78.7 mg/dL
STANDARD_DEVIATION 23.1 • n=7 Participants
|
91.6 mg/dL
STANDARD_DEVIATION 18.4 • n=6 Participants
|
89.8 mg/dL
STANDARD_DEVIATION 20.7 • n=10 Participants
|
94.2 mg/dL
STANDARD_DEVIATION 24.0 • n=14 Participants
|
96.5 mg/dL
STANDARD_DEVIATION 27.5 • n=4 Participants
|
89.1 mg/dL
STANDARD_DEVIATION 26.1 • n=4 Participants
|
|
Total Cholesterol/HDL-C Ratio
|
3.988 ratio
STANDARD_DEVIATION 1.154 • n=5 Participants
|
3.859 ratio
STANDARD_DEVIATION 1.396 • n=7 Participants
|
4.112 ratio
STANDARD_DEVIATION 1.311 • n=5 Participants
|
4.002 ratio
STANDARD_DEVIATION 1.100 • n=4 Participants
|
3.980 ratio
STANDARD_DEVIATION 1.224 • n=21 Participants
|
4.100 ratio
STANDARD_DEVIATION 1.636 • n=10 Participants
|
3.704 ratio
STANDARD_DEVIATION 1.260 • n=115 Participants
|
3.461 ratio
STANDARD_DEVIATION 1.093 • n=6 Participants
|
3.748 ratio
STANDARD_DEVIATION 1.099 • n=6 Participants
|
3.540 ratio
STANDARD_DEVIATION 1.100 • n=64 Participants
|
3.696 ratio
STANDARD_DEVIATION 1.371 • n=17 Participants
|
3.462 ratio
STANDARD_DEVIATION 1.000 • n=21 Participants
|
4.044 ratio
STANDARD_DEVIATION 1.685 • n=22 Participants
|
3.891 ratio
STANDARD_DEVIATION 1.234 • n=8 Participants
|
3.915 ratio
STANDARD_DEVIATION 1.216 • n=16 Participants
|
4.178 ratio
STANDARD_DEVIATION 1.932 • n=135 Participants
|
3.086 ratio
STANDARD_DEVIATION 0.728 • n=136 Participants
|
3.547 ratio
STANDARD_DEVIATION 1.355 • n=44 Participants
|
3.413 ratio
STANDARD_DEVIATION 1.355 • n=667 Participants
|
3.307 ratio
STANDARD_DEVIATION 1.061 • n=7 Participants
|
3.733 ratio
STANDARD_DEVIATION 1.079 • n=6 Participants
|
3.595 ratio
STANDARD_DEVIATION 1.345 • n=10 Participants
|
4.196 ratio
STANDARD_DEVIATION 1.436 • n=14 Participants
|
3.924 ratio
STANDARD_DEVIATION 1.420 • n=4 Participants
|
3.786 ratio
STANDARD_DEVIATION 1.353 • n=4 Participants
|
|
Apolipoprotein B/Apolipoprotein A1 Ratio
|
0.666 ratio
STANDARD_DEVIATION 0.216 • n=5 Participants
|
0.647 ratio
STANDARD_DEVIATION 0.266 • n=7 Participants
|
0.692 ratio
STANDARD_DEVIATION 0.243 • n=5 Participants
|
0.640 ratio
STANDARD_DEVIATION 0.169 • n=4 Participants
|
0.663 ratio
STANDARD_DEVIATION 0.217 • n=21 Participants
|
0.659 ratio
STANDARD_DEVIATION 0.249 • n=10 Participants
|
0.603 ratio
STANDARD_DEVIATION 0.221 • n=115 Participants
|
0.571 ratio
STANDARD_DEVIATION 0.189 • n=6 Participants
|
0.640 ratio
STANDARD_DEVIATION 0.234 • n=6 Participants
|
0.560 ratio
STANDARD_DEVIATION 0.157 • n=64 Participants
|
0.593 ratio
STANDARD_DEVIATION 0.227 • n=17 Participants
|
0.562 ratio
STANDARD_DEVIATION 0.171 • n=21 Participants
|
0.661 ratio
STANDARD_DEVIATION 0.273 • n=22 Participants
|
0.636 ratio
STANDARD_DEVIATION 0.207 • n=8 Participants
|
0.640 ratio
STANDARD_DEVIATION 0.249 • n=16 Participants
|
0.676 ratio
STANDARD_DEVIATION 0.341 • n=135 Participants
|
0.479 ratio
STANDARD_DEVIATION 0.129 • n=136 Participants
|
0.562 ratio
STANDARD_DEVIATION 0.217 • n=44 Participants
|
0.538 ratio
STANDARD_DEVIATION 0.227 • n=667 Participants
|
0.536 ratio
STANDARD_DEVIATION 0.193 • n=7 Participants
|
0.611 ratio
STANDARD_DEVIATION 0.179 • n=6 Participants
|
0.581 ratio
STANDARD_DEVIATION 0.174 • n=10 Participants
|
0.657 ratio
STANDARD_DEVIATION 0.193 • n=14 Participants
|
0.639 ratio
STANDARD_DEVIATION 0.224 • n=4 Participants
|
0.614 ratio
STANDARD_DEVIATION 0.229 • n=4 Participants
|
|
Lipoprotein(a) Concentration
|
31.5 nmol/L
n=5 Participants
|
41.0 nmol/L
n=7 Participants
|
37.0 nmol/L
n=5 Participants
|
33.0 nmol/L
n=4 Participants
|
27.0 nmol/L
n=21 Participants
|
49.0 nmol/L
n=10 Participants
|
53.0 nmol/L
n=115 Participants
|
50.0 nmol/L
n=6 Participants
|
25.0 nmol/L
n=6 Participants
|
61.5 nmol/L
n=64 Participants
|
32.0 nmol/L
n=17 Participants
|
24.5 nmol/L
n=21 Participants
|
34.0 nmol/L
n=22 Participants
|
35.0 nmol/L
n=8 Participants
|
38.0 nmol/L
n=16 Participants
|
32.0 nmol/L
n=135 Participants
|
28.5 nmol/L
n=136 Participants
|
33.0 nmol/L
n=44 Participants
|
41.0 nmol/L
n=667 Participants
|
49.5 nmol/L
n=7 Participants
|
36.5 nmol/L
n=6 Participants
|
28.0 nmol/L
n=10 Participants
|
32.5 nmol/L
n=14 Participants
|
37.0 nmol/L
n=4 Participants
|
34.0 nmol/L
n=4 Participants
|
|
Triglyceride Concentration
|
112.0 mg/dL
n=5 Participants
|
108.0 mg/dL
n=7 Participants
|
129.5 mg/dL
n=5 Participants
|
119.0 mg/dL
n=4 Participants
|
135.0 mg/dL
n=21 Participants
|
119.0 mg/dL
n=10 Participants
|
104.0 mg/dL
n=115 Participants
|
104.0 mg/dL
n=6 Participants
|
133.0 mg/dL
n=6 Participants
|
109.0 mg/dL
n=64 Participants
|
104.0 mg/dL
n=17 Participants
|
106.5 mg/dL
n=21 Participants
|
112.5 mg/dL
n=22 Participants
|
134.0 mg/dL
n=8 Participants
|
116.0 mg/dL
n=16 Participants
|
121.0 mg/dL
n=135 Participants
|
128.0 mg/dL
n=136 Participants
|
116.0 mg/dL
n=44 Participants
|
102.0 mg/dL
n=667 Participants
|
119.5 mg/dL
n=7 Participants
|
124.0 mg/dL
n=6 Participants
|
106.0 mg/dL
n=10 Participants
|
129.0 mg/dL
n=14 Participants
|
110.0 mg/dL
n=4 Participants
|
116.0 mg/dL
n=4 Participants
|
|
Very Low Density Lipoprotein Cholesterol (VLDL-C) Concentration
|
22.0 mg/dL
n=5 Participants
|
22.0 mg/dL
n=7 Participants
|
25.5 mg/dL
n=5 Participants
|
24.0 mg/dL
n=4 Participants
|
27.0 mg/dL
n=21 Participants
|
24.0 mg/dL
n=10 Participants
|
21.0 mg/dL
n=115 Participants
|
21.0 mg/dL
n=6 Participants
|
26.5 mg/dL
n=6 Participants
|
22.0 mg/dL
n=64 Participants
|
21.0 mg/dL
n=17 Participants
|
21.0 mg/dL
n=21 Participants
|
22.5 mg/dL
n=22 Participants
|
27.0 mg/dL
n=8 Participants
|
23.0 mg/dL
n=16 Participants
|
24.0 mg/dL
n=135 Participants
|
26.0 mg/dL
n=136 Participants
|
23.0 mg/dL
n=44 Participants
|
20.0 mg/dL
n=667 Participants
|
24.0 mg/dL
n=7 Participants
|
25.0 mg/dL
n=6 Participants
|
21.0 mg/dL
n=10 Participants
|
26.0 mg/dL
n=14 Participants
|
22.0 mg/dL
n=4 Participants
|
23.0 mg/dL
n=4 Participants
|
|
HDL-C Concentration
|
54.1 mg/dL
STANDARD_DEVIATION 16.6 • n=5 Participants
|
57.9 mg/dL
STANDARD_DEVIATION 18.4 • n=7 Participants
|
54.1 mg/dL
STANDARD_DEVIATION 17.2 • n=5 Participants
|
52.7 mg/dL
STANDARD_DEVIATION 13.7 • n=4 Participants
|
56.0 mg/dL
STANDARD_DEVIATION 17.9 • n=21 Participants
|
56.1 mg/dL
STANDARD_DEVIATION 17.8 • n=10 Participants
|
50.6 mg/dL
STANDARD_DEVIATION 15.6 • n=115 Participants
|
50.9 mg/dL
STANDARD_DEVIATION 13.0 • n=6 Participants
|
48.7 mg/dL
STANDARD_DEVIATION 12.6 • n=6 Participants
|
51.6 mg/dL
STANDARD_DEVIATION 15.1 • n=64 Participants
|
48.5 mg/dL
STANDARD_DEVIATION 12.9 • n=17 Participants
|
50.8 mg/dL
STANDARD_DEVIATION 13.5 • n=21 Participants
|
52.1 mg/dL
STANDARD_DEVIATION 14.9 • n=22 Participants
|
55.5 mg/dL
STANDARD_DEVIATION 16.0 • n=8 Participants
|
54.5 mg/dL
STANDARD_DEVIATION 15.0 • n=16 Participants
|
54.0 mg/dL
STANDARD_DEVIATION 16.0 • n=135 Participants
|
52.8 mg/dL
STANDARD_DEVIATION 12.9 • n=136 Participants
|
56.0 mg/dL
STANDARD_DEVIATION 18.7 • n=44 Participants
|
53.2 mg/dL
STANDARD_DEVIATION 16.4 • n=667 Participants
|
53.8 mg/dL
STANDARD_DEVIATION 14.6 • n=7 Participants
|
55.0 mg/dL
STANDARD_DEVIATION 14.2 • n=6 Participants
|
59.9 mg/dL
STANDARD_DEVIATION 21.8 • n=10 Participants
|
49.7 mg/dL
STANDARD_DEVIATION 12.6 • n=14 Participants
|
57.3 mg/dL
STANDARD_DEVIATION 17.4 • n=4 Participants
|
53.5 mg/dL
STANDARD_DEVIATION 15.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
9.86 percent change
Standard Error 2.53
|
0.97 percent change
Standard Error 2.82
|
-21.96 percent change
Standard Error 2.63
|
-17.08 percent change
Standard Error 2.78
|
-61.56 percent change
Standard Error 1.81
|
-58.19 percent change
Standard Error 1.99
|
14.49 percent change
Standard Error 4.42
|
11.83 percent change
Standard Error 3.85
|
-14.60 percent change
Standard Error 4.29
|
-19.80 percent change
Standard Error 3.85
|
-61.80 percent change
Standard Error 3.04
|
-58.68 percent change
Standard Error 2.74
|
8.12 percent change
Standard Error 2.68
|
5.10 percent change
Standard Error 2.62
|
-60.09 percent change
Standard Error 1.94
|
-59.40 percent change
Standard Error 1.87
|
9.42 percent change
Standard Error 3.60
|
2.59 percent change
Standard Error 4.30
|
-58.89 percent change
Standard Error 2.58
|
-52.40 percent change
Standard Error 2.98
|
4.70 percent change
Standard Error 3.61
|
3.40 percent change
Standard Error 4.94
|
-65.86 percent change
Standard Error 3.05
|
-57.02 percent change
Standard Error 3.93
|
PRIMARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
|
8.54 percent change
Standard Error 2.24
|
0.35 percent change
Standard Error 2.60
|
-23.88 percent change
Standard Error 2.34
|
-18.98 percent change
Standard Error 2.57
|
-61.41 percent change
Standard Error 1.61
|
-62.47 percent change
Standard Error 1.83
|
13.12 percent change
Standard Error 3.99
|
9.76 percent change
Standard Error 3.39
|
-16.85 percent change
Standard Error 3.88
|
-21.25 percent change
Standard Error 3.42
|
-61.80 percent change
Standard Error 2.77
|
-65.05 percent change
Standard Error 2.42
|
7.55 percent change
Standard Error 2.39
|
2.79 percent change
Standard Error 2.50
|
-59.33 percent change
Standard Error 1.74
|
-63.79 percent change
Standard Error 1.76
|
6.57 percent change
Standard Error 3.11
|
-0.02 percent change
Standard Error 3.51
|
-59.08 percent change
Standard Error 2.23
|
-62.94 percent change
Standard Error 2.44
|
3.26 percent change
Standard Error 3.40
|
6.00 percent change
Standard Error 4.80
|
-66.17 percent change
Standard Error 2.93
|
-62.45 percent change
Standard Error 3.85
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
|
6.8 mg/dL
Standard Error 3.7
|
-0.4 mg/dL
Standard Error 4.4
|
-32.4 mg/dL
Standard Error 3.8
|
-25.1 mg/dL
Standard Error 4.3
|
-76.8 mg/dL
Standard Error 2.7
|
-80.1 mg/dL
Standard Error 3.1
|
11.0 mg/dL
Standard Error 5.0
|
5.5 mg/dL
Standard Error 3.7
|
-13.0 mg/dL
Standard Error 4.9
|
-21.3 mg/dL
Standard Error 3.7
|
-58.8 mg/dL
Standard Error 3.5
|
-60.1 mg/dL
Standard Error 2.6
|
6.5 mg/dL
Standard Error 3.5
|
0.1 mg/dL
Standard Error 4.2
|
-68.9 mg/dL
Standard Error 2.5
|
-77.8 mg/dL
Standard Error 3.0
|
3.4 mg/dL
Standard Error 3.0
|
-4.8 mg/dL
Standard Error 4.2
|
-52.3 mg/dL
Standard Error 2.2
|
-55.3 mg/dL
Standard Error 2.9
|
-5.7 mg/dL
Standard Error 5.2
|
1.7 mg/dL
Standard Error 6.5
|
-83.8 mg/dL
Standard Error 4.5
|
-78.4 mg/dL
Standard Error 5.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in LDL-C at Week 12
|
8.6 mg/dL
Standard Error 4.0
|
0.8 mg/dL
Standard Error 4.5
|
-30.1 mg/dL
Standard Error 4.1
|
-23.3 mg/dL
Standard Error 4.5
|
-77.0 mg/dL
Standard Error 2.9
|
-75.1 mg/dL
Standard Error 3.2
|
12.7 mg/dL
Standard Error 5.3
|
7.0 mg/dL
Standard Error 4.1
|
-9.9 mg/dL
Standard Error 5.2
|
-19.5 mg/dL
Standard Error 4.1
|
-59.0 mg/dL
Standard Error 3.7
|
-54.8 mg/dL
Standard Error 2.9
|
7.8 mg/dL
Standard Error 3.8
|
2.4 mg/dL
Standard Error 4.4
|
-69.2 mg/dL
Standard Error 2.7
|
-73.3 mg/dL
Standard Error 3.1
|
5.1 mg/dL
Standard Error 3.2
|
-2.0 mg/dL
Standard Error 4.7
|
-52.1 mg/dL
Standard Error 2.3
|
-46.7 mg/dL
Standard Error 3.3
|
-4.5 mg/dL
Standard Error 5.3
|
-0.6 mg/dL
Standard Error 6.6
|
-83.5 mg/dL
Standard Error 4.6
|
-72.5 mg/dL
Standard Error 5.2
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
|
6.80 percent change
Standard Error 2.07
|
1.28 percent change
Standard Error 2.44
|
-20.71 percent change
Standard Error 2.15
|
-16.56 percent change
Standard Error 2.41
|
-53.48 percent change
Standard Error 1.48
|
-56.09 percent change
Standard Error 1.71
|
10.74 percent change
Standard Error 3.59
|
8.45 percent change
Standard Error 3.13
|
-16.19 percent change
Standard Error 3.49
|
-18.79 percent change
Standard Error 3.16
|
-54.44 percent change
Standard Error 2.49
|
-56.31 percent change
Standard Error 2.23
|
7.02 percent change
Standard Error 2.11
|
3.73 percent change
Standard Error 2.32
|
-52.59 percent change
Standard Error 1.54
|
-55.47 percent change
Standard Error 1.64
|
6.19 percent change
Standard Error 2.61
|
1.58 percent change
Standard Error 2.90
|
-52.08 percent change
Standard Error 1.88
|
-55.72 percent change
Standard Error 2.01
|
0.74 percent change
Standard Error 3.23
|
6.81 percent change
Standard Error 4.35
|
-59.33 percent change
Standard Error 2.79
|
-56.01 percent change
Standard Error 3.49
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12
|
8.25 percent change
Standard Error 2.32
|
2.43 percent change
Standard Error 2.69
|
-18.27 percent change
Standard Error 2.40
|
-14.78 percent change
Standard Error 2.65
|
-53.39 percent change
Standard Error 1.66
|
-52.20 percent change
Standard Error 1.90
|
11.79 percent change
Standard Error 3.87
|
9.95 percent change
Standard Error 3.51
|
-14.34 percent change
Standard Error 3.75
|
-17.26 percent change
Standard Error 3.52
|
-54.84 percent change
Standard Error 2.66
|
-50.05 percent change
Standard Error 2.50
|
7.92 percent change
Standard Error 2.40
|
5.85 percent change
Standard Error 2.42
|
-52.04 percent change
Standard Error 1.74
|
-51.57 percent change
Standard Error 1.72
|
8.61 percent change
Standard Error 3.04
|
3.35 percent change
Standard Error 3.53
|
-50.97 percent change
Standard Error 2.18
|
-46.42 percent change
Standard Error 2.45
|
1.89 percent change
Standard Error 3.38
|
5.66 percent change
Standard Error 4.53
|
-59.02 percent change
Standard Error 2.87
|
-50.96 percent change
Standard Error 3.60
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
|
7.55 percent change
Standard Error 1.89
|
0.81 percent change
Standard Error 2.19
|
-17.29 percent change
Standard Error 2.00
|
-11.43 percent change
Standard Error 2.20
|
-50.95 percent change
Standard Error 1.38
|
-51.44 percent change
Standard Error 1.52
|
10.20 percent change
Standard Error 3.02
|
5.48 percent change
Standard Error 2.83
|
-14.22 percent change
Standard Error 2.98
|
-13.62 percent change
Standard Error 2.87
|
-49.14 percent change
Standard Error 2.13
|
-53.26 percent change
Standard Error 2.02
|
5.07 percent change
Standard Error 1.97
|
2.54 percent change
Standard Error 1.89
|
-49.79 percent change
Standard Error 1.46
|
-53.59 percent change
Standard Error 1.32
|
3.71 percent change
Standard Error 2.46
|
1.98 percent change
Standard Error 2.57
|
-47.07 percent change
Standard Error 1.76
|
-52.95 percent change
Standard Error 1.76
|
-0.31 percent change
Standard Error 3.02
|
2.49 percent change
Standard Error 4.67
|
-55.65 percent change
Standard Error 2.63
|
-54.37 percent change
Standard Error 3.93
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at Week 12
|
7.89 percent change
Standard Error 2.16
|
0.21 percent change
Standard Error 2.43
|
-15.98 percent change
Standard Error 2.26
|
-10.95 percent change
Standard Error 2.44
|
-50.90 percent change
Standard Error 1.56
|
-47.15 percent change
Standard Error 1.70
|
11.64 percent change
Standard Error 3.28
|
6.54 percent change
Standard Error 3.22
|
-12.31 percent change
Standard Error 3.20
|
-12.16 percent change
Standard Error 3.24
|
-49.77 percent change
Standard Error 2.28
|
-46.47 percent change
Standard Error 2.31
|
6.35 percent change
Standard Error 2.10
|
4.63 percent change
Standard Error 2.11
|
-50.15 percent change
Standard Error 1.54
|
-48.58 percent change
Standard Error 1.49
|
4.91 percent change
Standard Error 2.71
|
3.24 percent change
Standard Error 3.13
|
-45.61 percent change
Standard Error 1.93
|
-43.71 percent change
Standard Error 2.13
|
0.35 percent change
Standard Error 3.17
|
3.57 percent change
Standard Error 4.74
|
-55.95 percent change
Standard Error 2.72
|
-49.16 percent change
Standard Error 3.97
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
|
5.96 percent change
Standard Error 1.76
|
2.24 percent change
Standard Error 2.11
|
-14.39 percent change
Standard Error 1.83
|
-10.86 percent change
Standard Error 2.08
|
-40.44 percent change
Standard Error 1.26
|
-42.45 percent change
Standard Error 1.48
|
4.26 percent change
Standard Error 2.59
|
6.42 percent change
Standard Error 2.34
|
-11.92 percent change
Standard Error 2.52
|
-12.25 percent change
Standard Error 2.35
|
-40.22 percent change
Standard Error 1.80
|
-40.43 percent change
Standard Error 1.66
|
5.41 percent change
Standard Error 1.96
|
5.02 percent change
Standard Error 2.25
|
-39.33 percent change
Standard Error 1.43
|
-42.00 percent change
Standard Error 1.59
|
4.55 percent change
Standard Error 1.98
|
1.71 percent change
Standard Error 2.36
|
-36.04 percent change
Standard Error 1.42
|
-38.62 percent change
Standard Error 1.64
|
-0.14 percent change
Standard Error 2.79
|
5.45 percent change
Standard Error 3.50
|
-47.20 percent change
Standard Error 2.37
|
-43.17 percent change
Standard Error 2.85
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
|
6.09 percent change
Standard Error 2.02
|
2.80 percent change
Standard Error 2.31
|
-12.14 percent change
Standard Error 2.10
|
-9.85 percent change
Standard Error 2.28
|
-40.74 percent change
Standard Error 1.45
|
-40.07 percent change
Standard Error 1.63
|
4.31 percent change
Standard Error 2.75
|
6.18 percent change
Standard Error 2.73
|
-10.53 percent change
Standard Error 2.66
|
-11.06 percent change
Standard Error 2.73
|
-40.79 percent change
Standard Error 1.89
|
-36.25 percent change
Standard Error 1.94
|
4.68 percent change
Standard Error 2.28
|
6.07 percent change
Standard Error 2.36
|
-38.57 percent change
Standard Error 1.64
|
-39.26 percent change
Standard Error 1.68
|
5.96 percent change
Standard Error 2.28
|
2.69 percent change
Standard Error 2.80
|
-35.17 percent change
Standard Error 1.63
|
-32.30 percent change
Standard Error 1.94
|
-0.20 percent change
Standard Error 2.81
|
5.13 percent change
Standard Error 3.62
|
-47.24 percent change
Standard Error 2.38
|
-39.47 percent change
Standard Error 2.92
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
|
6.41 percent change
Standard Error 2.03
|
0.78 percent change
Standard Error 2.29
|
-15.77 percent change
Standard Error 2.14
|
-11.47 percent change
Standard Error 2.29
|
-53.56 percent change
Standard Error 1.48
|
-53.33 percent change
Standard Error 1.58
|
4.48 percent change
Standard Error 3.04
|
5.79 percent change
Standard Error 2.79
|
-15.17 percent change
Standard Error 2.99
|
-12.91 percent change
Standard Error 2.80
|
-52.43 percent change
Standard Error 2.14
|
-56.20 percent change
Standard Error 1.98
|
2.82 percent change
Standard Error 2.26
|
2.58 percent change
Standard Error 2.05
|
-52.46 percent change
Standard Error 1.67
|
-56.66 percent change
Standard Error 1.43
|
2.17 percent change
Standard Error 2.56
|
2.60 percent change
Standard Error 2.97
|
-48.47 percent change
Standard Error 1.83
|
-54.17 percent change
Standard Error 2.04
|
-1.00 percent change
Standard Error 3.12
|
-1.42 percent change
Standard Error 4.22
|
-58.76 percent change
Standard Error 2.73
|
-57.47 percent change
Standard Error 3.55
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
|
6.13 percent change
Standard Error 2.20
|
-1.21 percent change
Standard Error 2.41
|
-14.51 percent change
Standard Error 2.31
|
-12.33 percent change
Standard Error 2.41
|
-54.17 percent change
Standard Error 1.59
|
-49.65 percent change
Standard Error 1.69
|
4.19 percent change
Standard Error 3.25
|
6.50 percent change
Standard Error 3.18
|
-13.69 percent change
Standard Error 3.17
|
-12.19 percent change
Standard Error 3.17
|
-53.59 percent change
Standard Error 2.26
|
-50.76 percent change
Standard Error 2.26
|
1.44 percent change
Standard Error 2.30
|
4.00 percent change
Standard Error 2.27
|
-52.97 percent change
Standard Error 1.69
|
-52.13 percent change
Standard Error 1.60
|
1.64 percent change
Standard Error 2.75
|
3.16 percent change
Standard Error 3.51
|
-47.53 percent change
Standard Error 1.96
|
-45.65 percent change
Standard Error 2.39
|
-1.80 percent change
Standard Error 3.21
|
-0.52 percent change
Standard Error 4.29
|
-59.53 percent change
Standard Error 2.77
|
-52.56 percent change
Standard Error 3.59
|
SECONDARY outcome
Timeframe: Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
|
5.7 percentage of participants
Interval 1.9 to 15.4
|
5.6 percentage of participants
Interval 1.9 to 15.1
|
20.0 percentage of participants
Interval 11.2 to 33.0
|
16.7 percentage of participants
Interval 9.0 to 28.7
|
88.1 percentage of participants
Interval 80.7 to 92.9
|
85.8 percentage of participants
Interval 78.0 to 91.2
|
13.7 percentage of participants
Interval 6.8 to 25.7
|
9.3 percentage of participants
Interval 4.0 to 19.9
|
50.9 percentage of participants
Interval 38.1 to 63.6
|
62.3 percentage of participants
Interval 48.8 to 74.1
|
94.4 percentage of participants
Interval 88.4 to 97.4
|
92.5 percentage of participants
Interval 85.9 to 96.2
|
7.0 percentage of participants
Interval 2.8 to 16.7
|
5.3 percentage of participants
Interval 1.8 to 14.4
|
88.7 percentage of participants
Interval 81.2 to 93.4
|
89.9 percentage of participants
Interval 82.8 to 94.3
|
38.9 percentage of participants
Interval 27.0 to 52.2
|
28.8 percentage of participants
Interval 18.3 to 42.3
|
93.5 percentage of participants
Interval 87.1 to 96.8
|
94.5 percentage of participants
Interval 88.6 to 97.5
|
1.9 percentage of participants
Interval 0.3 to 9.8
|
3.9 percentage of participants
Interval 1.1 to 13.2
|
93.6 percentage of participants
Interval 87.3 to 96.9
|
88.5 percentage of participants
Interval 81.3 to 93.2
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
|
2.0 percentage of participants
Interval 0.3 to 10.3
|
5.9 percentage of participants
Interval 2.0 to 15.9
|
22.4 percentage of participants
Interval 13.0 to 35.9
|
19.2 percentage of participants
Interval 10.8 to 31.9
|
85.4 percentage of participants
Interval 77.4 to 91.0
|
84.2 percentage of participants
Interval 75.8 to 90.0
|
13.0 percentage of participants
Interval 6.1 to 25.7
|
9.8 percentage of participants
Interval 4.3 to 21.0
|
52.0 percentage of participants
Interval 38.5 to 65.2
|
55.8 percentage of participants
Interval 42.3 to 68.4
|
93.1 percentage of participants
Interval 86.5 to 96.6
|
91.0 percentage of participants
Interval 83.8 to 95.2
|
7.7 percentage of participants
Interval 3.0 to 18.2
|
5.5 percentage of participants
Interval 1.9 to 14.9
|
85.0 percentage of participants
Interval 76.7 to 90.7
|
86.5 percentage of participants
Interval 78.7 to 91.8
|
39.6 percentage of participants
Interval 27.6 to 53.1
|
28.0 percentage of participants
Interval 17.5 to 41.7
|
92.3 percentage of participants
Interval 85.6 to 96.1
|
92.3 percentage of participants
Interval 85.6 to 96.1
|
1.9 percentage of participants
Interval 0.3 to 10.1
|
6.4 percentage of participants
Interval 2.2 to 17.2
|
94.4 percentage of participants
Interval 88.4 to 97.4
|
84.8 percentage of participants
Interval 76.7 to 90.4
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
|
6.07 percent change
Standard Error 2.86
|
-0.77 percent change
Standard Error 3.28
|
1.44 percent change
Standard Error 3.02
|
6.85 percent change
Standard Error 3.29
|
-26.01 percent change
Standard Error 2.08
|
-22.64 percent change
Standard Error 2.27
|
-3.45 percent change
Standard Error 2.99
|
1.51 percent change
Standard Error 3.35
|
8.05 percent change
Standard Error 2.94
|
9.96 percent change
Standard Error 3.40
|
-23.97 percent change
Standard Error 2.10
|
-27.46 percent change
Standard Error 2.39
|
11.41 percent change
Standard Error 3.00
|
3.65 percent change
Standard Error 3.56
|
-24.26 percent change
Standard Error 2.21
|
-23.16 percent change
Standard Error 2.50
|
8.59 percent change
Standard Error 2.98
|
6.26 percent change
Standard Error 3.59
|
-24.96 percent change
Standard Error 2.12
|
-25.93 percent change
Standard Error 2.46
|
-10.57 percent change
Standard Error 4.49
|
-4.99 percent change
Standard Error 5.37
|
-38.64 percent change
Standard Error 3.92
|
-32.16 percent change
Standard Error 4.50
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at Week 12
|
7.34 percent change
Standard Error 3.13
|
-0.43 percent change
Standard Error 3.38
|
3.29 percent change
Standard Error 3.28
|
7.18 percent change
Standard Error 3.38
|
-25.87 percent change
Standard Error 2.26
|
-20.25 percent change
Standard Error 2.36
|
-2.23 percent change
Standard Error 3.35
|
3.41 percent change
Standard Error 3.54
|
8.01 percent change
Standard Error 3.26
|
10.20 percent change
Standard Error 3.57
|
-24.61 percent change
Standard Error 2.31
|
-24.68 percent change
Standard Error 2.53
|
11.40 percent change
Standard Error 3.37
|
4.49 percent change
Standard Error 3.68
|
-25.09 percent change
Standard Error 2.47
|
-20.85 percent change
Standard Error 2.59
|
10.38 percent change
Standard Error 3.09
|
10.21 percent change
Standard Error 4.36
|
-26.11 percent change
Standard Error 2.21
|
-21.97 percent change
Standard Error 2.97
|
-6.81 percent change
Standard Error 4.57
|
-1.06 percent change
Standard Error 5.67
|
-38.06 percent change
Standard Error 3.96
|
-29.23 percent change
Standard Error 4.68
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
|
6.49 percent change
Standard Error 3.94
|
9.17 percent change
Standard Error 4.41
|
-3.16 percent change
Standard Error 4.10
|
1.57 percent change
Standard Error 4.35
|
-5.61 percent change
Standard Error 2.81
|
-13.38 percent change
Standard Error 3.08
|
6.16 percent change
Standard Error 4.02
|
8.05 percent change
Standard Error 4.35
|
-8.10 percent change
Standard Error 3.92
|
-4.86 percent change
Standard Error 4.39
|
-9.27 percent change
Standard Error 2.80
|
-6.36 percent change
Standard Error 3.11
|
12.43 percent change
Standard Error 4.19
|
12.26 percent change
Standard Error 4.67
|
-10.28 percent change
Standard Error 3.04
|
-7.26 percent change
Standard Error 3.29
|
8.44 percent change
Standard Error 3.76
|
10.75 percent change
Standard Error 3.98
|
-9.15 percent change
Standard Error 2.70
|
-15.43 percent change
Standard Error 2.77
|
9.29 percent change
Standard Error 6.97
|
13.78 percent change
Standard Error 7.44
|
-11.67 percent change
Standard Error 5.97
|
-15.93 percent change
Standard Error 6.15
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at Week 12
|
8.27 percent change
Standard Error 5.23
|
14.35 percent change
Standard Error 5.92
|
-0.43 percent change
Standard Error 5.39
|
4.88 percent change
Standard Error 5.84
|
-3.79 percent change
Standard Error 3.72
|
-13.26 percent change
Standard Error 4.17
|
6.65 percent change
Standard Error 4.45
|
8.22 percent change
Standard Error 5.22
|
-7.40 percent change
Standard Error 4.32
|
-3.11 percent change
Standard Error 5.23
|
-10.07 percent change
Standard Error 3.05
|
-1.10 percent change
Standard Error 3.74
|
13.57 percent change
Standard Error 5.76
|
12.96 percent change
Standard Error 5.32
|
-4.46 percent change
Standard Error 4.16
|
-6.88 percent change
Standard Error 3.80
|
10.97 percent change
Standard Error 4.66
|
10.00 percent change
Standard Error 4.38
|
-5.58 percent change
Standard Error 3.34
|
-10.51 percent change
Standard Error 3.04
|
8.07 percent change
Standard Error 6.88
|
16.72 percent change
Standard Error 7.88
|
-13.71 percent change
Standard Error 5.91
|
-14.65 percent change
Standard Error 6.39
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
|
6.51 percent change
Standard Error 3.56
|
9.53 percent change
Standard Error 4.45
|
-5.35 percent change
Standard Error 3.74
|
1.77 percent change
Standard Error 4.41
|
-6.85 percent change
Standard Error 2.56
|
-11.77 percent change
Standard Error 3.11
|
6.24 percent change
Standard Error 4.03
|
8.31 percent change
Standard Error 4.26
|
-8.52 percent change
Standard Error 3.93
|
-6.13 percent change
Standard Error 4.31
|
-8.96 percent change
Standard Error 2.82
|
-6.38 percent change
Standard Error 3.05
|
12.86 percent change
Standard Error 3.95
|
12.54 percent change
Standard Error 4.58
|
-12.22 percent change
Standard Error 2.86
|
-7.25 percent change
Standard Error 3.23
|
7.06 percent change
Standard Error 3.76
|
8.13 percent change
Standard Error 3.72
|
-9.09 percent change
Standard Error 2.71
|
-15.05 percent change
Standard Error 2.58
|
8.64 percent change
Standard Error 6.01
|
16.37 percent change
Standard Error 7.15
|
-14.57 percent change
Standard Error 5.17
|
-16.50 percent change
Standard Error 5.87
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12
|
8.32 percent change
Standard Error 4.00
|
14.74 percent change
Standard Error 5.91
|
-4.61 percent change
Standard Error 4.19
|
3.45 percent change
Standard Error 5.89
|
-6.16 percent change
Standard Error 2.88
|
-11.73 percent change
Standard Error 4.16
|
6.73 percent change
Standard Error 4.45
|
8.54 percent change
Standard Error 5.00
|
-7.92 percent change
Standard Error 4.32
|
-6.00 percent change
Standard Error 5.04
|
-9.69 percent change
Standard Error 3.05
|
-1.06 percent change
Standard Error 3.58
|
13.79 percent change
Standard Error 5.05
|
12.47 percent change
Standard Error 5.31
|
-8.20 percent change
Standard Error 3.64
|
-6.28 percent change
Standard Error 3.78
|
10.09 percent change
Standard Error 4.65
|
8.59 percent change
Standard Error 4.37
|
-6.10 percent change
Standard Error 3.33
|
-9.95 percent change
Standard Error 3.03
|
7.63 percent change
Standard Error 6.26
|
20.97 percent change
Standard Error 7.53
|
-14.83 percent change
Standard Error 5.30
|
-15.86 percent change
Standard Error 6.09
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
|
-0.99 percent change
Standard Error 1.50
|
-0.45 percent change
Standard Error 1.94
|
-1.13 percent change
Standard Error 1.56
|
-0.92 percent change
Standard Error 1.92
|
5.54 percent change
Standard Error 1.07
|
7.66 percent change
Standard Error 1.37
|
4.48 percent change
Standard Error 1.73
|
-1.37 percent change
Standard Error 1.85
|
0.86 percent change
Standard Error 1.68
|
-0.59 percent change
Standard Error 1.86
|
8.44 percent change
Standard Error 1.20
|
7.76 percent change
Standard Error 1.31
|
0.87 percent change
Standard Error 1.52
|
-0.94 percent change
Standard Error 2.55
|
6.23 percent change
Standard Error 1.10
|
7.72 percent change
Standard Error 1.80
|
-0.60 percent change
Standard Error 1.56
|
-0.40 percent change
Standard Error 1.81
|
4.86 percent change
Standard Error 1.12
|
6.35 percent change
Standard Error 1.26
|
0.13 percent change
Standard Error 2.75
|
-2.14 percent change
Standard Error 2.72
|
10.35 percent change
Standard Error 2.26
|
6.71 percent change
Standard Error 2.25
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
A10 PBO Q2W
n=56 Participants
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 Participants
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 Participants
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 Participants
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 Participants
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 Participants
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in HDL-C at Week 12
|
0.22 percent change
Standard Error 1.72
|
0.01 percent change
Standard Error 2.02
|
-1.76 percent change
Standard Error 1.78
|
-0.40 percent change
Standard Error 1.99
|
7.04 percent change
Standard Error 1.23
|
7.88 percent change
Standard Error 1.42
|
5.02 percent change
Standard Error 1.88
|
0.30 percent change
Standard Error 2.01
|
0.62 percent change
Standard Error 1.83
|
0.21 percent change
Standard Error 2.01
|
9.09 percent change
Standard Error 1.29
|
7.36 percent change
Standard Error 1.43
|
2.87 percent change
Standard Error 1.87
|
-0.16 percent change
Standard Error 2.64
|
6.07 percent change
Standard Error 1.35
|
7.18 percent change
Standard Error 1.87
|
-0.39 percent change
Standard Error 1.86
|
0.73 percent change
Standard Error 1.98
|
4.65 percent change
Standard Error 1.34
|
5.57 percent change
Standard Error 1.37
|
1.14 percent change
Standard Error 2.96
|
-2.65 percent change
Standard Error 2.87
|
10.92 percent change
Standard Error 2.38
|
6.41 percent change
Standard Error 2.34
|
Adverse Events
A10 PBO Q2W
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
A10 PBO QM
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
A10 EZE (Q2W)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
A10 EZE (QM)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
A10 EvoMab Q2W
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
A10 EvoMab QM
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
A80 PBO Q2W
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
A80 PBO QM
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
A80 EZE (Q2W)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
A80 EZE (QM)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
A80 EvoMab Q2W
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
A80 EvoMab QM
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
R5 PBO Q2W
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
R5 PBO QM
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
R5 EvoMab Q2W
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
R5 EvoMab QM
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
R40 PBO Q2W
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
R40 PBO QM
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
R40 EvoMab Q2W
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
R40 EvoMab QM
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
S40 PBO Q2W
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
S40 PBO QM
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
S40 EvoMab Q2W
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
S40 EvoMab QM
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A10 PBO Q2W
n=56 participants at risk
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 participants at risk
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 participants at risk
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 participants at risk
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 participants at risk
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 participants at risk
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 participants at risk
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 participants at risk
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 participants at risk
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 participants at risk
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 participants at risk
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 participants at risk
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 participants at risk
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.88%
1/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.88%
1/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes simplex meningoencephalitis
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infected bites
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.87%
1/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Troponin increased
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.90%
1/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.87%
1/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.88%
1/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
1/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Coma
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Glomerulonephritis acute
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.87%
1/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.90%
1/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.87%
1/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
A10 PBO Q2W
n=56 participants at risk
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
|
A10 PBO QM
n=55 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
|
A10 EZE (Q2W)
n=56 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
|
A10 EZE (QM)
n=55 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A10 EvoMab Q2W
n=110 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A10 EvoMab QM
n=110 participants at risk
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 PBO Q2W
n=55 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 PBO QM
n=55 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
A80 EZE (Q2W)
n=56 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EZE (QM)
n=54 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
|
A80 EvoMab Q2W
n=109 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
|
A80 EvoMab QM
n=110 participants at risk
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
|
R5 PBO Q2W
n=58 participants at risk
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 PBO QM
n=57 participants at risk
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R5 EvoMab Q2W
n=113 participants at risk
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R5 EvoMab QM
n=115 participants at risk
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
R40 PBO Q2W
n=56 participants at risk
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 PBO QM
n=55 participants at risk
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
R40 EvoMab Q2W
n=111 participants at risk
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
R40 EvoMab QM
n=112 participants at risk
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
S40 PBO Q2W
n=56 participants at risk
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 PBO QM
n=55 participants at risk
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
|
S40 EvoMab Q2W
n=112 participants at risk
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
|
S40 EvoMab QM
n=115 participants at risk
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.4%
3/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.88%
1/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
4/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
4/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
2/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
3/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.9%
4/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.88%
1/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
2/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
5/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
6/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
2/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
3/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
4/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
3/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
1/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
3/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.87%
1/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
2/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.5%
3/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
1/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
2/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.90%
1/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
3/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
1/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.2%
3/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.88%
1/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
2/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.89%
1/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
3/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.87%
1/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
4/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.91%
1/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/54 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
3/110 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.2%
3/58 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/57 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.88%
1/113 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.87%
1/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/111 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
3/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
2/56 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
1/55 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/112 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
5/115 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER