Trial Outcomes & Findings for Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects (NCT NCT01375764)
NCT ID: NCT01375764
Last Updated: 2022-11-07
Results Overview
LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2022-11-07
Participant Flow
The study enrolled adults aged 18 to 75 years with hypercholesterolemia who were statin intolerant and with low-density lipoprotein cholesterol (LDL-C) levels above risk-based goals recommended by the National Cholesterol Education Program. The first patient enrolled on 28 July 2011; last patient enrolled 14 February 2012.
Randomization was stratified by screening LDL-C level (\< 130 mg/dL \[3.4 mmol/L\] or ≥ 130 mg/dL) and statin use at baseline (yes or no).
Participant milestones
| Measure |
Ezetimibe
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab + Ezetimibe
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
32
|
32
|
32
|
|
Overall Study
Received Treatment
|
32
|
30
|
32
|
31
|
32
|
|
Overall Study
COMPLETED
|
31
|
30
|
32
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Ezetimibe
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab + Ezetimibe
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
Baseline characteristics by cohort
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab + Ezetimibe
n=30 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=32 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
n=31 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
n=32 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 6.6 • n=93 Participants
|
62.0 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
62.2 years
STANDARD_DEVIATION 10.1 • n=27 Participants
|
62.3 years
STANDARD_DEVIATION 9.1 • n=483 Participants
|
60.0 years
STANDARD_DEVIATION 8.6 • n=36 Participants
|
61.8 years
STANDARD_DEVIATION 8.4 • n=10 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
100 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
57 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=93 Participants
|
5 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
8 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
1 participants
n=36 Participants
|
8 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
1 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
28 participants
n=93 Participants
|
24 participants
n=4 Participants
|
28 participants
n=27 Participants
|
29 participants
n=483 Participants
|
30 participants
n=36 Participants
|
139 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
1 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
2 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
30 participants
n=93 Participants
|
30 participants
n=4 Participants
|
32 participants
n=27 Participants
|
31 participants
n=483 Participants
|
32 participants
n=36 Participants
|
155 participants
n=10 Participants
|
|
Stratification Factor: LDL-C Level
< 130 mg/dL
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
2 participants
n=36 Participants
|
9 participants
n=10 Participants
|
|
Stratification Factor: LDL-C Level
≥ 130 mg/dL
|
30 participants
n=93 Participants
|
29 participants
n=4 Participants
|
30 participants
n=27 Participants
|
29 participants
n=483 Participants
|
30 participants
n=36 Participants
|
148 participants
n=10 Participants
|
|
Stratification Factor: Baseline Use of Statin
No
|
26 participants
n=93 Participants
|
26 participants
n=4 Participants
|
27 participants
n=27 Participants
|
27 participants
n=483 Participants
|
27 participants
n=36 Participants
|
133 participants
n=10 Participants
|
|
Stratification Factor: Baseline Use of Statin
Yes
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
5 participants
n=27 Participants
|
4 participants
n=483 Participants
|
5 participants
n=36 Participants
|
24 participants
n=10 Participants
|
|
LDL-C Concentration
|
182.9 mg/dL
STANDARD_DEVIATION 36.4 • n=93 Participants
|
194.4 mg/dL
STANDARD_DEVIATION 60.1 • n=4 Participants
|
194.8 mg/dL
STANDARD_DEVIATION 48.1 • n=27 Participants
|
190.3 mg/dL
STANDARD_DEVIATION 47.8 • n=483 Participants
|
203.5 mg/dL
STANDARD_DEVIATION 60.3 • n=36 Participants
|
193.2 mg/dL
STANDARD_DEVIATION 51.0 • n=10 Participants
|
|
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
|
213.7 mg/dL
STANDARD_DEVIATION 40.4 • n=93 Participants
|
219.8 mg/dL
STANDARD_DEVIATION 60.5 • n=4 Participants
|
225.5 mg/dL
STANDARD_DEVIATION 53.3 • n=27 Participants
|
222.9 mg/dL
STANDARD_DEVIATION 55.8 • n=483 Participants
|
240.6 mg/dL
STANDARD_DEVIATION 63.9 • n=36 Participants
|
224.6 mg/dL
STANDARD_DEVIATION 55.3 • n=10 Participants
|
|
Apolipoprotein B Concentration
|
138.0 mg/dL
STANDARD_DEVIATION 21.7 • n=93 Participants
|
138.8 mg/dL
STANDARD_DEVIATION 33.1 • n=4 Participants
|
143.0 mg/dL
STANDARD_DEVIATION 30.6 • n=27 Participants
|
144.9 mg/dL
STANDARD_DEVIATION 33.9 • n=483 Participants
|
150.8 mg/dL
STANDARD_DEVIATION 34.1 • n=36 Participants
|
143.2 mg/dL
STANDARD_DEVIATION 30.9 • n=10 Participants
|
|
Total Cholesterol/HDL-C Ratio
|
4.907 ratio
STANDARD_DEVIATION 1.553 • n=93 Participants
|
5.093 ratio
STANDARD_DEVIATION 2.416 • n=4 Participants
|
5.287 ratio
STANDARD_DEVIATION 1.816 • n=27 Participants
|
5.444 ratio
STANDARD_DEVIATION 2.308 • n=483 Participants
|
6.438 ratio
STANDARD_DEVIATION 2.834 • n=36 Participants
|
5.438 ratio
STANDARD_DEVIATION 2.265 • n=10 Participants
|
|
Apolipoprotein B/Apolipoprotein A-1 Ratio
|
0.841 ratio
STANDARD_DEVIATION 0.230 • n=93 Participants
|
0.882 ratio
STANDARD_DEVIATION 0.332 • n=4 Participants
|
0.906 ratio
STANDARD_DEVIATION 0.265 • n=27 Participants
|
0.916 ratio
STANDARD_DEVIATION 0.332 • n=483 Participants
|
1.055 ratio
STANDARD_DEVIATION 0.388 • n=36 Participants
|
0.921 ratio
STANDARD_DEVIATION 0.319 • n=10 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. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=32 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
n=31 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
n=32 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
|
-14.76 percent change
Standard Error 3.94
|
-40.77 percent change
Standard Error 3.96
|
-42.58 percent change
Standard Error 4.01
|
-50.70 percent change
Standard Error 3.98
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF and calculated LDL-C.
LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=30 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
|
-15.70 percent change
Standard Error 3.98
|
-62.98 percent change
Standard Error 4.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.
LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=32 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
n=31 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
n=32 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
|
-14.2 mg/dL
Standard Error 8.9
|
-66.8 mg/dL
Standard Error 8.9
|
-69.7 mg/dL
Standard Error 9.1
|
-90.8 mg/dL
Standard Error 9.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.
LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=30 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
|
-17.9 mg/dL
Standard Error 10.4
|
-109.8 mg/dL
Standard Error 11.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.
LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=32 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
n=31 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
n=32 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12
|
-14.97 percent change
Standard Error 3.54
|
-39.83 percent change
Standard Error 3.56
|
-41.63 percent change
Standard Error 3.61
|
-48.58 percent change
Standard Error 3.58
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.
LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=30 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
|
-14.83 percent change
Standard Error 3.59
|
-59.82 percent change
Standard Error 3.81
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.
LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=32 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
n=31 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
n=32 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
|
-12.20 percent change
Standard Error 3.37
|
-33.58 percent change
Standard Error 3.39
|
-34.33 percent change
Standard Error 3.43
|
-42.07 percent change
Standard Error 3.40
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=30 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
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: Ezetimibe Alone Versus Evolocumab + Ezetimibe
|
-10.84 percent change
Standard Error 3.45
|
-49.06 percent change
Standard Error 3.66
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=32 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
n=31 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
n=32 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
|
-9.61 percent change
Standard Error 3.20
|
-31.97 percent change
Standard Error 3.22
|
-33.52 percent change
Standard Error 3.26
|
-40.56 percent change
Standard Error 3.23
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=30 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
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: Ezetimibe Alone Versus Evolocumab + Ezetimibe
|
-11.52 percent change
Standard Error 3.61
|
-49.44 percent change
Standard Error 3.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=32 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
n=31 Participants
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
n=32 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
|
-11.36 percent change
Standard Error 3.16
|
-36.46 percent change
Standard Error 3.18
|
-38.17 percent change
Standard Error 3.22
|
-45.41 percent change
Standard Error 3.19
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Outcome measures
| Measure |
Ezetimibe
n=32 Participants
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=30 Participants
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
|
-10.74 percent change
Standard Error 3.55
|
-51.99 percent change
Standard Error 3.76
|
—
|
—
|
Adverse Events
Ezetimibe
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Evolocumab 280 mg
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Evolocumab 350 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Evolocumab 420 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Evolocumab + Ezetimibe
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetimibe
n=32 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=32 participants at risk
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
n=31 participants at risk
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
n=32 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab + Ezetimibe
n=30 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
1/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Ezetimibe
n=32 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
Evolocumab 280 mg
n=32 participants at risk
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 350 mg
n=31 participants at risk
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab 420 mg
n=32 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
|
Evolocumab + Ezetimibe
n=30 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
1/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
3/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
1/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
4/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cystitis
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
2/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
1/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
15.6%
5/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.5%
2/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
3/30 • 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
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
1/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
3/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
1/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.5%
2/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
1/30 • 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%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
1/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
2/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 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
|
9.4%
3/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.5%
2/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.6%
5/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
1/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
6/30 • 12 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
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
3/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
2/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
1/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
6/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
1/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 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
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.4%
3/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 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
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.2%
1/31 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/32 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/30 • 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