Trial Outcomes & Findings for Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2 (NCT NCT01763905)
NCT ID: NCT01763905
Last Updated: 2020-07-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
307 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2020-07-20
Participant Flow
Men and women ≥ 18 to ≤ 80 years of age who have tried at least 2 statins and were unable to tolerate any dose or increase in statin dose due to muscle-related side effects were eligible for this study. The first participant was enrolled on 24 January 2013 and the last participant enrolled on 29 August 2013.
Participants received subcutaneous placebo corresponding to the once monthly dose volume during a 6-week screening period. Those who completed the screening period and met final eligibility criteria were randomized 1:1:2:2 into 4 treatment groups. Randomization was stratified by low-density lipoprotein cholesterol (LDL-C) level and statin use.
Participant milestones
| Measure |
Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
103
|
102
|
|
Overall Study
COMPLETED
|
45
|
50
|
94
|
101
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
9
|
1
|
Reasons for withdrawal
| Measure |
Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
|
Overall Study
Decision by sponsor
|
5
|
0
|
8
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
Baseline characteristics by cohort
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
61.5 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
166 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
49 participants
n=5 Participants
|
46 participants
n=7 Participants
|
94 participants
n=5 Participants
|
98 participants
n=4 Participants
|
287 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
50 participants
n=5 Participants
|
49 participants
n=7 Participants
|
100 participants
n=5 Participants
|
101 participants
n=4 Participants
|
300 participants
n=21 Participants
|
|
Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C) Level
< 180 mg/dL
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
52 participants
n=4 Participants
|
156 participants
n=21 Participants
|
|
Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C) Level
≥ 180 mg/dL
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
51 participants
n=5 Participants
|
50 participants
n=4 Participants
|
151 participants
n=21 Participants
|
|
Stratification Factor: Baseline Statin Use
No
|
41 participants
n=5 Participants
|
42 participants
n=7 Participants
|
84 participants
n=5 Participants
|
82 participants
n=4 Participants
|
249 participants
n=21 Participants
|
|
Stratification Factor: Baseline Statin Use
Yes
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
20 participants
n=4 Participants
|
58 participants
n=21 Participants
|
|
LDL-C Concentration
|
194.7 mg/dL
STANDARD_DEVIATION 63.8 • n=5 Participants
|
195.2 mg/dL
STANDARD_DEVIATION 51.8 • n=7 Participants
|
192.0 mg/dL
STANDARD_DEVIATION 57.0 • n=5 Participants
|
192.2 mg/dL
STANDARD_DEVIATION 61.2 • n=4 Participants
|
193.1 mg/dL
STANDARD_DEVIATION 58.5 • n=21 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
|
231.4 mg/dL
STANDARD_DEVIATION 66.0 • n=5 Participants
|
232.9 mg/dL
STANDARD_DEVIATION 57.0 • n=7 Participants
|
227.9 mg/dL
STANDARD_DEVIATION 56.6 • n=5 Participants
|
222.1 mg/dL
STANDARD_DEVIATION 63.2 • n=4 Participants
|
227.4 mg/dL
STANDARD_DEVIATION 60.4 • n=21 Participants
|
|
Apolipoprotein B Concentration
|
140.0 mg/dL
STANDARD_DEVIATION 37.0 • n=5 Participants
|
140.0 mg/dL
STANDARD_DEVIATION 31.1 • n=7 Participants
|
140.2 mg/dL
STANDARD_DEVIATION 32.1 • n=5 Participants
|
133.1 mg/dL
STANDARD_DEVIATION 32.2 • n=4 Participants
|
137.8 mg/dL
STANDARD_DEVIATION 32.8 • n=21 Participants
|
|
Total Cholesterol/High-Density Lipoprotein Cholesterol Ratio
|
5.989 ratio
STANDARD_DEVIATION 2.190 • n=5 Participants
|
6.137 ratio
STANDARD_DEVIATION 1.787 • n=7 Participants
|
5.912 ratio
STANDARD_DEVIATION 1.929 • n=5 Participants
|
5.506 ratio
STANDARD_DEVIATION 1.925 • n=4 Participants
|
5.827 ratio
STANDARD_DEVIATION 1.956 • n=21 Participants
|
|
Apolipoprotein B/Apolipoprotein A1 Ratio
|
0.943 ratio
STANDARD_DEVIATION 0.282 • n=5 Participants
|
1.005 ratio
STANDARD_DEVIATION 0.294 • n=7 Participants
|
0.980 ratio
STANDARD_DEVIATION 0.318 • n=5 Participants
|
0.901 ratio
STANDARD_DEVIATION 0.283 • n=4 Participants
|
0.952 ratio
STANDARD_DEVIATION 0.298 • n=21 Participants
|
|
Lipoprotein(a) Concentration
|
106.3 nmol/L
STANDARD_DEVIATION 101.0 • n=5 Participants
|
76.6 nmol/L
STANDARD_DEVIATION 96.7 • n=7 Participants
|
66.2 nmol/L
STANDARD_DEVIATION 72.5 • n=5 Participants
|
70.9 nmol/L
STANDARD_DEVIATION 99.9 • n=4 Participants
|
76.2 nmol/L
STANDARD_DEVIATION 91.9 • n=21 Participants
|
|
Triglyceride Concentration
|
183.4 mg/dL
STANDARD_DEVIATION 79.8 • n=5 Participants
|
187.0 mg/dL
STANDARD_DEVIATION 81.5 • n=7 Participants
|
179.8 mg/dL
STANDARD_DEVIATION 80.0 • n=5 Participants
|
149.3 mg/dL
STANDARD_DEVIATION 63.1 • n=4 Participants
|
171.5 mg/dL
STANDARD_DEVIATION 76.3 • n=21 Participants
|
|
Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration
|
36.7 mg/dL
STANDARD_DEVIATION 16.0 • n=5 Participants
|
37.1 mg/dL
STANDARD_DEVIATION 15.8 • n=7 Participants
|
35.2 mg/dL
STANDARD_DEVIATION 14.5 • n=5 Participants
|
29.9 mg/dL
STANDARD_DEVIATION 12.6 • n=4 Participants
|
34.0 mg/dL
STANDARD_DEVIATION 14.6 • n=21 Participants
|
|
High-Density Lipoprotein Cholesterol (HDL-C)
|
52.4 mg/dL
STANDARD_DEVIATION 18.3 • n=5 Participants
|
48.0 mg/dL
STANDARD_DEVIATION 11.0 • n=7 Participants
|
51.1 mg/dL
STANDARD_DEVIATION 16.4 • n=5 Participants
|
54.0 mg/dL
STANDARD_DEVIATION 16.0 • n=4 Participants
|
51.8 mg/dL
STANDARD_DEVIATION 15.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set (all randomized participants who received at least 1 dose of investigational product (subcutaneously or orally)) with available data (no imputation was performed).
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C at Week 12
|
-18.08 percent change
Standard Error 2.52
|
-15.05 percent change
Standard Error 2.13
|
-56.14 percent change
Standard Error 1.91
|
-52.60 percent change
Standard Error 1.58
|
PRIMARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set with available data (no imputation was performed).
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
|
-19.21 percent change
Standard Error 2.40
|
-16.62 percent change
Standard Error 2.03
|
-56.11 percent change
Standard Error 1.83
|
-55.31 percent change
Standard Error 1.53
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
|
-39.1 mg/dL
Standard Error 5.1
|
-33.0 mg/dL
Standard Error 4.5
|
-105.4 mg/dL
Standard Error 3.9
|
-103.6 mg/dL
Standard Error 3.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in LDL-C at Week 12
|
-36.2 mg/dL
Standard Error 5.4
|
-30.2 mg/dL
Standard Error 4.7
|
-106.0 mg/dL
Standard Error 4.1
|
-99.0 mg/dL
Standard Error 3.5
|
SECONDARY outcome
Timeframe: Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)
|
2.0 percentage of participants
Interval 0.4 to 10.5
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
45.5 percentage of participants
Interval 36.2 to 55.2
|
42.0 percentage of participants
Interval 32.8 to 51.8
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12
|
2.0 percentage of participants
Interval 0.4 to 10.7
|
0.0 percentage of participants
Interval 0.0 to 7.9
|
50.0 percentage of participants
Interval 40.3 to 59.7
|
37.5 percentage of participants
Interval 28.5 to 47.5
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
|
-17.18 percent change
Standard Error 2.15
|
-14.54 percent change
Standard Error 1.86
|
-48.72 percent change
Standard Error 1.64
|
-49.13 percent change
Standard Error 1.40
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12
|
-16.53 percent change
Standard Error 2.30
|
-13.16 percent change
Standard Error 1.93
|
-48.62 percent change
Standard Error 1.74
|
-46.15 percent change
Standard Error 1.43
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full anlaysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
|
-13.67 percent change
Standard Error 2.15
|
-11.02 percent change
Standard Error 2.21
|
-45.88 percent change
Standard Error 1.68
|
-46.01 percent change
Standard Error 1.65
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B at Week 12
|
-12.95 percent change
Standard Error 2.32
|
-9.97 percent change
Standard Error 2.34
|
-45.81 percent change
Standard Error 1.79
|
-43.07 percent change
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12
|
-13.44 percent change
Standard Error 2.14
|
-11.20 percent change
Standard Error 2.16
|
-40.83 percent change
Standard Error 1.65
|
-41.14 percent change
Standard Error 1.62
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12
|
-14.13 percent change
Standard Error 2.30
|
-9.92 percent change
Standard Error 2.34
|
-40.42 percent change
Standard Error 1.75
|
-38.57 percent change
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
|
-13.00 percent change
Standard Error 2.27
|
-11.94 percent change
Standard Error 2.56
|
-47.86 percent change
Standard Error 1.77
|
-48.31 percent change
Standard Error 1.92
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
|
-13.14 percent change
Standard Error 2.47
|
-11.37 percent change
Standard Error 2.71
|
-47.66 percent change
Standard Error 1.90
|
-45.51 percent change
Standard Error 2.01
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12
|
-2.30 percent change
Standard Error 3.36
|
1.55 percent change
Standard Error 4.01
|
-26.20 percent change
Standard Error 2.64
|
-23.72 percent change
Standard Error 2.97
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) at Week 12
|
-1.74 percent change
Standard Error 3.58
|
5.81 percent change
Standard Error 5.10
|
-27.03 percent change
Standard Error 2.78
|
-22.07 percent change
Standard Error 3.66
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
|
-3.74 percent change
Standard Error 3.88
|
-0.32 percent change
Standard Error 4.65
|
-6.32 percent change
Standard Error 2.94
|
-6.73 percent change
Standard Error 3.44
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides at Week 12
|
-5.47 percent change
Standard Error 4.25
|
2.16 percent change
Standard Error 5.52
|
-3.88 percent change
Standard Error 3.18
|
-2.53 percent change
Standard Error 3.98
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12
|
0.33 percent change
Standard Error 1.98
|
1.44 percent change
Standard Error 2.03
|
5.48 percent change
Standard Error 1.51
|
7.18 percent change
Standard Error 1.51
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
|
1.77 percent change
Standard Error 2.22
|
1.64 percent change
Standard Error 2.22
|
5.34 percent change
Standard Error 1.67
|
6.47 percent change
Standard Error 1.63
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12
|
-5.76 percent change
Standard Error 3.80
|
-2.93 percent change
Standard Error 4.41
|
-7.60 percent change
Standard Error 2.89
|
-6.46 percent change
Standard Error 3.21
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set
Outcome measures
| Measure |
Ezetimibe (Q2W)
n=51 Participants
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 Participants
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 Participants
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 Participants
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12
|
-5.49 percent change
Standard Error 4.05
|
-2.25 percent change
Standard Error 5.11
|
-6.16 percent change
Standard Error 3.08
|
-2.18 percent change
Standard Error 3.60
|
Adverse Events
Ezetimibe (Q2W)
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Ezetimibe (QM)
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Evolocumab Q2W
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Evolocumab QM
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetimibe (Q2W)
n=51 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 participants at risk
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage III
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cartilage graft
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.98%
1/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Osteotomy
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.98%
1/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Spinal decompression
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Ezetimibe (Q2W)
n=51 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Ezetimibe (QM)
n=51 participants at risk
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
|
Evolocumab Q2W
n=103 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
|
Evolocumab QM
n=102 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
3/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.8%
4/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
3/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.8%
5/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
3/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
6/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
7.8%
4/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.8%
6/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
3/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
6/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site erythema
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
3/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
5.9%
3/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
3/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
5/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
3/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
5/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.8%
8/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.7%
7/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
21.6%
11/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.8%
7/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.8%
9/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.8%
12/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.8%
6/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
4/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.8%
12/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.8%
4/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
3/51 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/102 • From the first dose of blinded investigational product until the end of the study (up to 14 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER