Trial Outcomes & Findings for LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy (NCT NCT01380730)
NCT ID: NCT01380730
Last Updated: 2022-11-15
Results Overview
LDL-C was measured using ultracentrifugation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
631 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2022-11-15
Participant Flow
This study enrolled adults aged 18 - 80 years who were on a statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, and fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL. The first patient enrolled on 18 July 2011 and the last patient enrolled on 22 December 2011.
Eligible participants were randomized equally into 1 of 8 treatment groups. Randomization was stratified by screening LDL-C level (\< 130 mg/dL or ≥ 130 mg/dL) and ezetimibe use at baseline (yes or no).
Participant milestones
| Measure |
Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
78
|
79
|
79
|
79
|
78
|
79
|
79
|
80
|
|
Overall Study
Received Treatment
|
78
|
77
|
79
|
79
|
78
|
79
|
79
|
80
|
|
Overall Study
COMPLETED
|
78
|
79
|
79
|
79
|
77
|
79
|
79
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
Baseline characteristics by cohort
| Measure |
Placebo Q2W
n=78 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=77 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=79 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=79 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=78 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=79 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=79 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=80 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Total
n=629 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
60.1 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
59.4 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
58.8 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 10.2 • n=31 Participants
|
60.3 years
STANDARD_DEVIATION 8.4 • n=30 Participants
|
61.9 years
STANDARD_DEVIATION 8.8 • n=3 Participants
|
60.9 years
STANDARD_DEVIATION 10.3 • n=6 Participants
|
60.5 years
STANDARD_DEVIATION 9.5 • n=114 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
40 Participants
n=30 Participants
|
38 Participants
n=3 Participants
|
44 Participants
n=6 Participants
|
319 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
39 Participants
n=30 Participants
|
41 Participants
n=3 Participants
|
36 Participants
n=6 Participants
|
310 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
1 participants
n=30 Participants
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
3 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
1 participants
n=31 Participants
|
2 participants
n=30 Participants
|
2 participants
n=3 Participants
|
1 participants
n=6 Participants
|
12 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=99 Participants
|
0 participants
n=107 Participants
|
6 participants
n=206 Participants
|
8 participants
n=7 Participants
|
9 participants
n=31 Participants
|
8 participants
n=30 Participants
|
4 participants
n=3 Participants
|
9 participants
n=6 Participants
|
50 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
0 participants
n=31 Participants
|
2 participants
n=30 Participants
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
3 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
72 participants
n=99 Participants
|
74 participants
n=107 Participants
|
72 participants
n=206 Participants
|
67 participants
n=7 Participants
|
67 participants
n=31 Participants
|
64 participants
n=30 Participants
|
72 participants
n=3 Participants
|
70 participants
n=6 Participants
|
558 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
2 participants
n=30 Participants
|
1 participants
n=3 Participants
|
0 participants
n=6 Participants
|
3 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
0 participants
n=7 Participants
|
6 participants
n=31 Participants
|
1 participants
n=30 Participants
|
0 participants
n=3 Participants
|
2 participants
n=6 Participants
|
21 participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
77 participants
n=99 Participants
|
71 participants
n=107 Participants
|
74 participants
n=206 Participants
|
79 participants
n=7 Participants
|
72 participants
n=31 Participants
|
78 participants
n=30 Participants
|
79 participants
n=3 Participants
|
78 participants
n=6 Participants
|
608 participants
n=114 Participants
|
|
Stratification Factor: LDL-C Level
< 130 mg/dL
|
51 participants
n=99 Participants
|
51 participants
n=107 Participants
|
51 participants
n=206 Participants
|
51 participants
n=7 Participants
|
52 participants
n=31 Participants
|
51 participants
n=30 Participants
|
52 participants
n=3 Participants
|
53 participants
n=6 Participants
|
412 participants
n=114 Participants
|
|
Stratification Factor: LDL-C Level
≥ 130 mg/dL
|
27 participants
n=99 Participants
|
26 participants
n=107 Participants
|
28 participants
n=206 Participants
|
28 participants
n=7 Participants
|
26 participants
n=31 Participants
|
28 participants
n=30 Participants
|
27 participants
n=3 Participants
|
27 participants
n=6 Participants
|
217 participants
n=114 Participants
|
|
Stratification Factor: Baseline Ezetimibe Use
No
|
71 participants
n=99 Participants
|
69 participants
n=107 Participants
|
72 participants
n=206 Participants
|
72 participants
n=7 Participants
|
71 participants
n=31 Participants
|
72 participants
n=30 Participants
|
72 participants
n=3 Participants
|
73 participants
n=6 Participants
|
572 participants
n=114 Participants
|
|
Stratification Factor: Baseline Ezetimibe Use
Yes
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
7 participants
n=206 Participants
|
7 participants
n=7 Participants
|
7 participants
n=31 Participants
|
7 participants
n=30 Participants
|
7 participants
n=3 Participants
|
7 participants
n=6 Participants
|
57 participants
n=114 Participants
|
|
LDL-C Concentration
|
122.2 mg/dL
STANDARD_DEVIATION 27.1 • n=99 Participants
|
124.9 mg/dL
STANDARD_DEVIATION 30.6 • n=107 Participants
|
121.4 mg/dL
STANDARD_DEVIATION 24.4 • n=206 Participants
|
127.4 mg/dL
STANDARD_DEVIATION 32.1 • n=7 Participants
|
120.9 mg/dL
STANDARD_DEVIATION 25.1 • n=31 Participants
|
122.0 mg/dL
STANDARD_DEVIATION 28.8 • n=30 Participants
|
123.2 mg/dL
STANDARD_DEVIATION 27.1 • n=3 Participants
|
120.8 mg/dL
STANDARD_DEVIATION 26.5 • n=6 Participants
|
122.8 mg/dL
STANDARD_DEVIATION 27.7 • n=114 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
|
146.9 mg/dL
STANDARD_DEVIATION 29.9 • n=99 Participants
|
150.2 mg/dL
STANDARD_DEVIATION 36.5 • n=107 Participants
|
145.3 mg/dL
STANDARD_DEVIATION 29.9 • n=206 Participants
|
151.2 mg/dL
STANDARD_DEVIATION 37.2 • n=7 Participants
|
145.3 mg/dL
STANDARD_DEVIATION 26.2 • n=31 Participants
|
146.3 mg/dL
STANDARD_DEVIATION 33.3 • n=30 Participants
|
150.0 mg/dL
STANDARD_DEVIATION 29.1 • n=3 Participants
|
144.4 mg/dL
STANDARD_DEVIATION 31.2 • n=6 Participants
|
147.4 mg/dL
STANDARD_DEVIATION 31.8 • n=114 Participants
|
|
Apolipoprotein B Concentration
|
99.9 mg/dL
STANDARD_DEVIATION 17.0 • n=99 Participants
|
101.6 mg/dL
STANDARD_DEVIATION 20.0 • n=107 Participants
|
99.9 mg/dL
STANDARD_DEVIATION 16.8 • n=206 Participants
|
103.6 mg/dL
STANDARD_DEVIATION 22.3 • n=7 Participants
|
98.8 mg/dL
STANDARD_DEVIATION 16.6 • n=31 Participants
|
101.3 mg/dL
STANDARD_DEVIATION 21.2 • n=30 Participants
|
102.6 mg/dL
STANDARD_DEVIATION 18.9 • n=3 Participants
|
99.9 mg/dL
STANDARD_DEVIATION 18.6 • n=6 Participants
|
100.9 mg/dL
STANDARD_DEVIATION 19.0 • n=114 Participants
|
|
Total Cholesterol/HDL-C ratio
|
3.940 ratio
STANDARD_DEVIATION 1.016 • n=99 Participants
|
4.057 ratio
STANDARD_DEVIATION 1.303 • n=107 Participants
|
4.002 ratio
STANDARD_DEVIATION 1.243 • n=206 Participants
|
4.128 ratio
STANDARD_DEVIATION 1.473 • n=7 Participants
|
3.932 ratio
STANDARD_DEVIATION 1.022 • n=31 Participants
|
4.007 ratio
STANDARD_DEVIATION 1.300 • n=30 Participants
|
4.118 ratio
STANDARD_DEVIATION 0.963 • n=3 Participants
|
3.885 ratio
STANDARD_DEVIATION 1.090 • n=6 Participants
|
4.008 ratio
STANDARD_DEVIATION 1.184 • n=114 Participants
|
|
Apolipoprotein B/Apolipoprotein A-1 Ratio
|
0.660 ratio
STANDARD_DEVIATION 0.155 • n=99 Participants
|
0.676 ratio
STANDARD_DEVIATION 0.194 • n=107 Participants
|
0.675 ratio
STANDARD_DEVIATION 0.191 • n=206 Participants
|
0.695 ratio
STANDARD_DEVIATION 0.219 • n=7 Participants
|
0.649 ratio
STANDARD_DEVIATION 0.155 • n=31 Participants
|
0.662 ratio
STANDARD_DEVIATION 0.199 • n=30 Participants
|
0.687 ratio
STANDARD_DEVIATION 0.175 • n=3 Participants
|
0.653 ratio
STANDARD_DEVIATION 0.177 • n=6 Participants
|
0.670 ratio
STANDARD_DEVIATION 0.184 • n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing ultracentrifugation LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.
LDL-C was measured using ultracentrifugation.
Outcome measures
| Measure |
Placebo Q2W
n=78 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=77 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=79 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=79 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=78 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=79 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=79 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=80 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
2.76 percent change
Standard Error 2.39
|
-0.98 percent change
Standard Error 2.51
|
-39.06 percent change
Standard Error 2.39
|
-57.48 percent change
Standard Error 2.39
|
-63.34 percent change
Standard Error 2.40
|
-42.82 percent change
Standard Error 2.52
|
-50.98 percent change
Standard Error 2.51
|
-51.31 percent change
Standard Error 2.53
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
LDL-C was measured using ultracentrifugation.
Outcome measures
| Measure |
Placebo Q2W
n=78 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=77 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=79 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=79 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=78 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=79 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=79 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=80 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in LDL-C at Week 12
|
-0.2 mg/dL
Standard Error 3.4
|
-3.2 mg/dL
Standard Error 3.3
|
-50.9 mg/dL
Standard Error 3.4
|
-77.6 mg/dL
Standard Error 3.5
|
-79.5 mg/dL
Standard Error 3.4
|
-53.7 mg/dL
Standard Error 3.3
|
-64.3 mg/dL
Standard Error 3.3
|
-64.3 mg/dL
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
Outcome measures
| Measure |
Placebo Q2W
n=78 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=77 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=79 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=79 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=78 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=79 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=79 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=80 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
|
2.21 percent change
Standard Error 2.20
|
-1.26 percent change
Standard Error 2.26
|
-36.23 percent change
Standard Error 2.20
|
-53.21 percent change
Standard Error 2.20
|
-59.19 percent change
Standard Error 2.21
|
-39.05 percent change
Standard Error 2.27
|
-47.05 percent change
Standard Error 2.26
|
-48.83 percent change
Standard Error 2.27
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
Outcome measures
| Measure |
Placebo Q2W
n=78 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=77 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=79 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=79 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=78 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=79 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=79 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=80 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at Week 12
|
5.86 percent change
Standard Error 2.15
|
3.22 percent change
Standard Error 2.25
|
-28.88 percent change
Standard Error 2.15
|
-44.29 percent change
Standard Error 2.14
|
-50.59 percent change
Standard Error 2.15
|
-31.16 percent change
Standard Error 2.26
|
-37.55 percent change
Standard Error 2.26
|
-38.81 percent change
Standard Error 2.27
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
Outcome measures
| Measure |
Placebo Q2W
n=78 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=77 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=79 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=79 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=78 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=79 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=79 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=80 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
|
2.64 percent change
Standard Error 1.97
|
-2.00 percent change
Standard Error 1.90
|
-28.76 percent change
Standard Error 1.97
|
-40.73 percent change
Standard Error 1.97
|
-45.09 percent change
Standard Error 1.98
|
-29.73 percent change
Standard Error 1.91
|
-37.97 percent change
Standard Error 1.91
|
-37.66 percent change
Standard Error 1.92
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
Outcome measures
| Measure |
Placebo Q2W
n=78 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=77 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=79 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=79 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=78 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=79 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=79 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=80 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
|
-0.30 percent change
Standard Error 2.13
|
-0.35 percent change
Standard Error 2.38
|
-35.04 percent change
Standard Error 2.13
|
-47.60 percent change
Standard Error 2.12
|
-53.73 percent change
Standard Error 2.14
|
-34.11 percent change
Standard Error 2.40
|
-42.74 percent change
Standard Error 2.39
|
-43.28 percent change
Standard Error 2.40
|
Adverse Events
Placebo Q2W
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo Q4W
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Evolocumab 70 mg Q2W
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Evolocumab 105 mg Q2W
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Evolocumab 140 mg Q2W
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Evolocumab 280 mg Q4W
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Evolocumab 350 mg Q4W
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Evolocumab 420 mg Q4W
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Q2W
n=78 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=77 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=79 participants at risk
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=79 participants at risk
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=78 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=79 participants at risk
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=79 participants at risk
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=80 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 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 cancer
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Social circumstances
Physical assault
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Coronary artery bypass
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo Q2W
n=78 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=77 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Evolocumab 70 mg Q2W
n=79 participants at risk
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=79 participants at risk
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=78 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=79 participants at risk
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=79 participants at risk
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=80 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.7%
6/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.5%
5/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.4%
9/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
8/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
7/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
8/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
8/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
8/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
2/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
4/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
4/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
3/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
4/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
5/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
2/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
4/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
4/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
4/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
5/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
2.6%
2/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
6/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 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
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
4/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/80 • 12 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%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
4/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
4/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
2.6%
2/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
4/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/80 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/77 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/78 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.6%
6/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/80 • 12 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