Trial Outcomes & Findings for Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels (NCT NCT01375777)
NCT ID: NCT01375777
Last Updated: 2022-11-08
Results Overview
LDL-C was measured using ultracentrifugation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
411 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2022-11-08
Participant Flow
This study enrolled adults 18 - 75 years with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and \< 190 mg/dL, fasting triglycerides ≤ 400 mg/dL and a National Cholesterol Education Program Adult Treatment Panel III Framingham risk score of 10% or less. First patient enrolled 06 July 2011, last patient enrolled 25 November 2011.
Participants were randomized with equal allocation into 1 of 9 treatment groups. Randomization was stratified on the basis of screening LDL-C concentration (\< 130 mg/dL \[3.4 mmol/L\] or ≥ 130 mg/dL).
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.
|
Ezetimibe
Participants received 10 mg ezetimibe orally once a day 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
|
46
|
45
|
46
|
45
|
46
|
45
|
46
|
46
|
46
|
|
Overall Study
Received Treatment
|
45
|
45
|
45
|
45
|
46
|
45
|
45
|
45
|
45
|
|
Overall Study
COMPLETED
|
44
|
42
|
45
|
45
|
45
|
44
|
44
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
0
|
1
|
1
|
2
|
2
|
2
|
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.
|
Ezetimibe
Participants received 10 mg ezetimibe orally once a day 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
Withdrawal by Subject
|
0
|
2
|
1
|
0
|
1
|
1
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
Baseline characteristics by cohort
| Measure |
Placebo Q2W
n=45 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=45 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Ezetimibe
n=45 Participants
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 70 mg Q2W
n=45 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=46 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=45 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=45 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=45 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=45 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Total
n=406 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
48.3 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
52.8 years
STANDARD_DEVIATION 11.6 • n=8 Participants
|
49.3 years
STANDARD_DEVIATION 10.3 • n=8 Participants
|
50.9 years
STANDARD_DEVIATION 13.1 • n=24 Participants
|
50.1 years
STANDARD_DEVIATION 12.0 • n=42 Participants
|
50.6 years
STANDARD_DEVIATION 11.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
33 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
267 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
139 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
3 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=8 Participants
|
1 participants
n=8 Participants
|
2 participants
n=24 Participants
|
2 participants
n=42 Participants
|
17 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
7 participants
n=4 Participants
|
5 participants
n=21 Participants
|
4 participants
n=8 Participants
|
8 participants
n=8 Participants
|
6 participants
n=24 Participants
|
10 participants
n=42 Participants
|
64 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
35 participants
n=5 Participants
|
33 participants
n=4 Participants
|
37 participants
n=21 Participants
|
39 participants
n=8 Participants
|
35 participants
n=8 Participants
|
36 participants
n=24 Participants
|
33 participants
n=42 Participants
|
319 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
8 participants
n=8 Participants
|
7 participants
n=8 Participants
|
5 participants
n=24 Participants
|
10 participants
n=42 Participants
|
56 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
ot Hispanic or Latino
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
40 participants
n=5 Participants
|
40 participants
n=4 Participants
|
41 participants
n=21 Participants
|
37 participants
n=8 Participants
|
38 participants
n=8 Participants
|
40 participants
n=24 Participants
|
35 participants
n=42 Participants
|
350 participants
n=42 Participants
|
|
Stratification Factor: LDL-C level
< 130 mg/dL
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
14 participants
n=4 Participants
|
15 participants
n=21 Participants
|
14 participants
n=8 Participants
|
15 participants
n=8 Participants
|
15 participants
n=24 Participants
|
14 participants
n=42 Participants
|
131 participants
n=42 Participants
|
|
Stratification Factor: LDL-C level
≥ 130 mg/dL
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
30 participants
n=5 Participants
|
31 participants
n=4 Participants
|
31 participants
n=21 Participants
|
31 participants
n=8 Participants
|
30 participants
n=8 Participants
|
30 participants
n=24 Participants
|
31 participants
n=42 Participants
|
275 participants
n=42 Participants
|
|
LDL-C Concentration
|
147.0 mg/dL
STANDARD_DEVIATION 21.0 • n=5 Participants
|
142.3 mg/dL
STANDARD_DEVIATION 24.3 • n=7 Participants
|
144.2 mg/dL
STANDARD_DEVIATION 25.8 • n=5 Participants
|
143.1 mg/dL
STANDARD_DEVIATION 21.7 • n=4 Participants
|
141.5 mg/dL
STANDARD_DEVIATION 22.3 • n=21 Participants
|
139.8 mg/dL
STANDARD_DEVIATION 21.1 • n=8 Participants
|
141.1 mg/dL
STANDARD_DEVIATION 21.8 • n=8 Participants
|
136.6 mg/dL
STANDARD_DEVIATION 20.8 • n=24 Participants
|
138.9 mg/dL
STANDARD_DEVIATION 21.9 • n=42 Participants
|
141.6 mg/dL
STANDARD_DEVIATION 22.3 • n=42 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
|
173.8 mg/dL
STANDARD_DEVIATION 30.5 • n=5 Participants
|
169.1 mg/dL
STANDARD_DEVIATION 27.7 • n=7 Participants
|
170.0 mg/dL
STANDARD_DEVIATION 32.0 • n=5 Participants
|
169.0 mg/dL
STANDARD_DEVIATION 24.5 • n=4 Participants
|
169.2 mg/dL
STANDARD_DEVIATION 24.3 • n=21 Participants
|
163.8 mg/dL
STANDARD_DEVIATION 23.7 • n=8 Participants
|
166.3 mg/dL
STANDARD_DEVIATION 27.8 • n=8 Participants
|
161.1 mg/dL
STANDARD_DEVIATION 26.1 • n=24 Participants
|
167.9 mg/dL
STANDARD_DEVIATION 29.6 • n=42 Participants
|
167.8 mg/dL
STANDARD_DEVIATION 27.4 • n=42 Participants
|
|
Apolipoprotein B Concentration
|
111.7 mg/dL
STANDARD_DEVIATION 17.1 • n=5 Participants
|
110.4 mg/dL
STANDARD_DEVIATION 17.2 • n=7 Participants
|
109.9 mg/dL
STANDARD_DEVIATION 17.7 • n=5 Participants
|
108.7 mg/dL
STANDARD_DEVIATION 15.7 • n=4 Participants
|
108.5 mg/dL
STANDARD_DEVIATION 15.2 • n=21 Participants
|
107.2 mg/dL
STANDARD_DEVIATION 16.3 • n=8 Participants
|
109.2 mg/dL
STANDARD_DEVIATION 15.7 • n=8 Participants
|
105.8 mg/dL
STANDARD_DEVIATION 15.9 • n=24 Participants
|
110.2 mg/dL
STANDARD_DEVIATION 18.4 • n=42 Participants
|
109.1 mg/dL
STANDARD_DEVIATION 16.5 • n=42 Participants
|
|
Total Cholesterol/HDL-C Ratio
|
4.477 ratio
STANDARD_DEVIATION 1.293 • n=5 Participants
|
4.793 ratio
STANDARD_DEVIATION 1.836 • n=7 Participants
|
4.670 ratio
STANDARD_DEVIATION 1.258 • n=5 Participants
|
4.335 ratio
STANDARD_DEVIATION 1.090 • n=4 Participants
|
4.571 ratio
STANDARD_DEVIATION 1.269 • n=21 Participants
|
4.181 ratio
STANDARD_DEVIATION 1.131 • n=8 Participants
|
4.500 ratio
STANDARD_DEVIATION 1.154 • n=8 Participants
|
4.335 ratio
STANDARD_DEVIATION 1.282 • n=24 Participants
|
4.741 ratio
STANDARD_DEVIATION 1.656 • n=42 Participants
|
4.512 ratio
STANDARD_DEVIATION 1.351 • n=42 Participants
|
|
Apolipoprotein B/Apolipoprotein A-1 Ratio
|
0.729 ratio
STANDARD_DEVIATION 0.180 • n=5 Participants
|
0.785 ratio
STANDARD_DEVIATION 0.322 • n=7 Participants
|
0.752 ratio
STANDARD_DEVIATION 0.176 • n=5 Participants
|
0.705 ratio
STANDARD_DEVIATION 0.161 • n=4 Participants
|
0.744 ratio
STANDARD_DEVIATION 0.168 • n=21 Participants
|
0.709 ratio
STANDARD_DEVIATION 0.175 • n=8 Participants
|
0.751 ratio
STANDARD_DEVIATION 0.161 • n=8 Participants
|
0.706 ratio
STANDARD_DEVIATION 0.185 • n=24 Participants
|
0.758 ratio
STANDARD_DEVIATION 0.191 • n=42 Participants
|
0.738 ratio
STANDARD_DEVIATION 0.196 • n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing ultracentrifugation (UC) 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=45 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=45 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Ezetimibe
n=45 Participants
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 70 mg Q2W
n=45 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=46 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=45 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=45 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=45 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=45 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
|
-3.71 percent change
Standard Error 2.66
|
4.54 percent change
Standard Error 2.64
|
-14.26 percent change
Standard Error 2.60
|
-40.98 percent change
Standard Error 2.64
|
-43.87 percent change
Standard Error 2.60
|
-50.93 percent change
Standard Error 2.66
|
-39.02 percent change
Standard Error 2.57
|
-43.20 percent change
Standard Error 2.57
|
-47.98 percent change
Standard Error 2.58
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using LOCF.
LDL-C was measured using ultracentrifugation.
Outcome measures
| Measure |
Placebo Q2W
n=45 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=45 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Ezetimibe
n=45 Participants
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 70 mg Q2W
n=45 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=46 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=45 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=45 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=45 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=45 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
|
-3.4 mg/dL
Standard Error 3.9
|
7.3 mg/dL
Standard Error 3.7
|
-19.2 mg/dL
Standard Error 3.6
|
-55.7 mg/dL
Standard Error 3.7
|
-66.0 mg/dL
Standard Error 3.7
|
-69.3 mg/dL
Standard Error 3.6
|
-53.5 mg/dL
Standard Error 3.6
|
-56.7 mg/dL
Standard Error 3.6
|
-65.0 mg/dL
Standard Error 3.6
|
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=45 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=45 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Ezetimibe
n=45 Participants
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 70 mg Q2W
n=45 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=46 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=45 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=45 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=45 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=45 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
|
-2.89 percent change
Standard Error 2.40
|
-0.25 percent change
Standard Error 2.30
|
-15.53 percent change
Standard Error 2.36
|
-37.95 percent change
Standard Error 2.38
|
-39.68 percent change
Standard Error 2.34
|
-48.04 percent change
Standard Error 2.40
|
-37.94 percent change
Standard Error 2.24
|
-42.14 percent change
Standard Error 2.24
|
-47.36 percent change
Standard Error 2.25
|
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=45 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=45 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Ezetimibe
n=45 Participants
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 70 mg Q2W
n=45 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=46 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=45 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=45 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=45 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=45 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
|
-0.33 percent change
Standard Error 2.28
|
0.19 percent change
Standard Error 2.28
|
-11.17 percent change
Standard Error 2.19
|
-32.66 percent change
Standard Error 2.26
|
-36.20 percent change
Standard Error 2.23
|
-44.52 percent change
Standard Error 2.28
|
-33.04 percent change
Standard Error 2.21
|
-37.73 percent change
Standard Error 2.21
|
-42.29 percent change
Standard Error 2.22
|
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=45 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=45 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Ezetimibe
n=45 Participants
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 70 mg Q2W
n=45 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=46 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=45 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=45 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=45 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=45 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
|
-1.21 percent change
Standard Error 2.17
|
-3.39 percent change
Standard Error 2.11
|
-16.65 percent change
Standard Error 1.99
|
-30.07 percent change
Standard Error 2.15
|
-33.13 percent change
Standard Error 2.12
|
-38.70 percent change
Standard Error 2.17
|
-32.07 percent change
Standard Error 2.05
|
-34.60 percent change
Standard Error 2.05
|
-39.97 percent change
Standard Error 2.06
|
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=45 Participants
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=45 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Ezetimibe
n=45 Participants
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 70 mg Q2W
n=45 Participants
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=46 Participants
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=45 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=45 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=45 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=45 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
|
2.03 percent change
Standard Error 2.40
|
0.14 percent change
Standard Error 2.46
|
-12.35 percent change
Standard Error 2.33
|
-32.80 percent change
Standard Error 2.38
|
-38.30 percent change
Standard Error 2.35
|
-48.13 percent change
Standard Error 2.40
|
-36.10 percent change
Standard Error 2.39
|
-40.43 percent change
Standard Error 2.39
|
-45.33 percent change
Standard Error 2.40
|
Adverse Events
Placebo Q2W
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Q4W
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Ezetimibe
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Evolocumab 70 mg Q2W
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Evolocumab 105 mg Q2W
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Evolocumab 140 mg Q2W
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Evolocumab 280 mg Q4W
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Evolocumab 350 mg Q4W
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Evolocumab 420 mg Q4W
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Q2W
n=45 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=45 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Ezetimibe
n=45 participants at risk
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 70 mg Q2W
n=45 participants at risk
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=46 participants at risk
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=45 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=45 participants at risk
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=45 participants at risk
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=45 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 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=45 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
|
Placebo Q4W
n=45 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
|
Ezetimibe
n=45 participants at risk
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 70 mg Q2W
n=45 participants at risk
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 105 mg Q2W
n=46 participants at risk
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 140 mg Q2W
n=45 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
|
Evolocumab 280 mg Q4W
n=45 participants at risk
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg Q4W
n=45 participants at risk
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg Q4W
n=45 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site induration
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.5%
3/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.9%
4/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
2/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 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
|
11.1%
5/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
5/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
2/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.9%
4/45 • 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
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.9%
4/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.3%
2/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
3/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.5%
3/46 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
2/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
1/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/45 • 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